Trial Outcomes & Findings for Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA) (NCT NCT00048542)

Last Updated: 2011-08-22

Results Overview

The primary efficacy endpoint was the number of adalimumab-treated subjects in the non-MTX stratum with disease flare during the Double-Blind Phase compared with the number of placebo-treated subjects in the non-MTX stratum with disease flare during the double-blind phase. Subjects met the criteria for disease flare if they had 1) \>= 30% worsening in at least 3 of the 6 Juvenile Rheumatoid Arthritis (JRA) core set criteria and a minimum of 2 active joints, and 2) \>= 30% improvement in not more than 1 of the 6 JRA core set criteria.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

171 participants

Primary outcome timeframe

Week 16 to Week 48 (32 weeks)

Results posted on

2011-08-22

Participant Flow

Subjects were enrolled at 31 sites between 19 September 2002 and 13 January 2005.

A total of 171 participants entered the Open-Label Lead-In (OL-LI) phase and received adalimumab. Of these 171 participants, 160 participants completed the OL-LI phase, and 133 participants entered the 32-week Double-Blind Phase (75 in the MTX stratum; 58 in the non-MTX stratum) and were randomized to adalimumab or placebo.

Participant milestones

Participant milestones
Measure	Double-Blind Adalimumab + MTX Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.	Double-Blind Placebo + MTX Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.	Double-Blind Adalimumab Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Open-Label Extension BSA Adalimumab + MTX Subjects in the methotrexate (MTX) stratum received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow) concomitantly with MTX treatment during the Open-Label Extension BSA Phase of the study.	Open-Label Extension BSA Adalimumab Subjects in the non-methotrexate (MTX) stratum received adalimumab (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose SC eow) without concomitant MTX treatment during the Open-Label Extension BSA Phase.	Open-Label Extension FD Adalimumab + MTX Subjects in the methotrexate (MTX) stratum received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which only body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.	Open-Label Extension FD Adalimumab Subjects in the non-methotrexate (MTX) stratum received adalimumab without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
Double-Blind Phase STARTED	38	37	30	28	0	0	0	0
Double-Blind Phase COMPLETED	35	36	29	28	0	0	0	0
Double-Blind Phase NOT COMPLETED	3	1	1	0	0	0	0	0
Open-Label Extension BSA Phase STARTED	0	0	0	0	71	57	0	0
Open-Label Extension BSA Phase COMPLETED	0	0	0	0	59	47	0	0
Open-Label Extension BSA Phase NOT COMPLETED	0	0	0	0	12	10	0	0
Open-Label Extension Fixed Dose Phase STARTED	0	0	0	0	0	0	59	47
Open-Label Extension Fixed Dose Phase COMPLETED	0	0	0	0	0	0	37	25
Open-Label Extension Fixed Dose Phase NOT COMPLETED	0	0	0	0	0	0	22	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Double-Blind Adalimumab + MTX Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.	Double-Blind Placebo + MTX Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.	Double-Blind Adalimumab Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Open-Label Extension BSA Adalimumab + MTX Subjects in the methotrexate (MTX) stratum received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow) concomitantly with MTX treatment during the Open-Label Extension BSA Phase of the study.	Open-Label Extension BSA Adalimumab Subjects in the non-methotrexate (MTX) stratum received adalimumab (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose SC eow) without concomitant MTX treatment during the Open-Label Extension BSA Phase.	Open-Label Extension FD Adalimumab + MTX Subjects in the methotrexate (MTX) stratum received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which only body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.	Open-Label Extension FD Adalimumab Subjects in the non-methotrexate (MTX) stratum received adalimumab without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
Double-Blind Phase Withdrawal by Subject	0	1	0	0	0	0	0
Double-Blind Phase Protocol Violation	0	0	1	0	0	0	0
Double-Blind Phase Sponsor request or decision	2	0	0	0	0	0	0
Double-Blind Phase Randomized in error	1	0	0	0	0	0	0
Open-Label Extension BSA Phase Withdrawal by Subject	0	0	0	3	6	0	0
Open-Label Extension BSA Phase Protocol Violation	0	0	0	0	1	0	0
Open-Label Extension BSA Phase Sponsor request or decision	0	0	0	5	1	0	0
Open-Label Extension BSA Phase Adverse Event	0	0	0	1	1	0	0
Open-Label Extension BSA Phase Lack of Efficacy	0	0	0	3	1	0	0
Open-Label Extension Fixed Dose Phase Withdrawal by Subject	0	0	0	0	0	6	3
Open-Label Extension Fixed Dose Phase Protocol Violation	0	0	0	0	0	1	1
Open-Label Extension Fixed Dose Phase Sponsor request or decision	0	0	0	0	0	6	7
Open-Label Extension Fixed Dose Phase Adverse Event	0	0	0	0	0	2	2
Open-Label Extension Fixed Dose Phase Lack of Efficacy	0	0	0	0	0	2	1
Open-Label Extension Fixed Dose Phase Lost to Follow-up	0	0	0	0	0	5	8

Baseline Characteristics

Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Double-Blind Adalimumab + MTX n=38 Participants Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.	Double-Blind Placebo + MTX n=37 Participants Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.	Double-Blind Adalimumab n=30 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=28 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Total n=133 Participants Total of all reporting groups
Sex: Female, Male Female	30 Participants n=5 Participants	30 Participants n=7 Participants	23 Participants n=5 Participants	20 Participants n=4 Participants	103 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	30 Participants n=21 Participants
Age Continuous	11.7 years STANDARD_DEVIATION 3.29 • n=5 Participants	10.8 years STANDARD_DEVIATION 3.36 • n=7 Participants	11.1 years STANDARD_DEVIATION 4.13 • n=5 Participants	11.3 years STANDARD_DEVIATION 3.77 • n=4 Participants	11.2 years STANDARD_DEVIATION 3.64 • n=21 Participants

PRIMARY outcome

Timeframe: Week 16 to Week 48 (32 weeks)

Population: All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the non-MTX stratum. Missing values were treated as disease flare.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=30 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=28 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase	13 Participants	20 Participants	—	—

SECONDARY outcome

Timeframe: Week 16

Population: All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.

Responders met the following criteria: \>= 30% improvement in \>= 3 of 6 JRA core set criteria, and \>= 30% worsening in not more than 1 JRA criterion, compared with the open-label baseline. JRA core set criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion \[LOM\] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=85 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=86 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Number of Subjects Meeting Pediatric American College of Rheumatology 30% (PedACR30) Response Criteria at the End of the Open-Label Lead-In Phase	80 Participants	64 Participants	—	—

SECONDARY outcome

Timeframe: Week 16 to Week 48 (32 Weeks)

Population: All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the MTX stratum. Missing values were treated as disease flare.

Subjects met criteria for disease flare if they had \>= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and \>= 30% improvement in not more than 1 JRA criterion. JRA core set criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=38 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=37 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Number of Subjects in the MTX Stratum With Disease Flare During the Double-Blind Phase	14 Participants	24 Participants	—	—

SECONDARY outcome

Timeframe: Week 16 to Week 48 (32 weeks)

Population: All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the non-MTX stratum.

A log rank test was performed and the Kaplan-Meier curve for time to disease flare from double-blind baseline (Week 16) to Week 48 was generated. Disease flare was defined as a \>= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and \>= 30% improvement in not more than 1 JRA criterion. The percentage of subjects without disease flare at each time point is presented.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=30 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=28 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum Week 20	90.0 Percent participants w/o disease flare	78.6 Percent participants w/o disease flare	—	—
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum Week 24	83.3 Percent participants w/o disease flare	64.3 Percent participants w/o disease flare	—	—
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum Week 28	80.0 Percent participants w/o disease flare	60.7 Percent participants w/o disease flare	—	—
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum Week 32	70.0 Percent participants w/o disease flare	46.4 Percent participants w/o disease flare	—	—
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum Week 36	66.7 Percent participants w/o disease flare	46.4 Percent participants w/o disease flare	—	—
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum Week 40	60.0 Percent participants w/o disease flare	39.3 Percent participants w/o disease flare	—	—
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum Week 44	60.0 Percent participants w/o disease flare	32.1 Percent participants w/o disease flare	—	—
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum Week 48	56.7 Percent participants w/o disease flare	28.6 Percent participants w/o disease flare	—	—

SECONDARY outcome

Timeframe: Week 16 to Week 48 (32 weeks)

Population: All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the MTX stratum.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=38 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=37 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum Week 40	63.2 Percent participants w/o disease flare	45.9 Percent participants w/o disease flare	—	—
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum Week 20	86.8 Percent participants w/o disease flare	83.8 Percent participants w/o disease flare	—	—
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum Week 24	78.9 Percent participants w/o disease flare	70.3 Percent participants w/o disease flare	—	—
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum Week 28	68.4 Percent participants w/o disease flare	59.5 Percent participants w/o disease flare	—	—
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum Week 32	68.4 Percent participants w/o disease flare	56.8 Percent participants w/o disease flare	—	—
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum Week 36	63.2 Percent participants w/o disease flare	48.6 Percent participants w/o disease flare	—	—
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum Week 44	63.2 Percent participants w/o disease flare	43.2 Percent participants w/o disease flare	—	—
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum Week 48	63.2 Percent participants w/o disease flare	35.1 Percent participants w/o disease flare	—	—

SECONDARY outcome

Timeframe: Week 48

Responders met the following criteria: \>= 30% improvement in \>= 3 of 6 JIA core set criteria, and \>= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core criteria are included in PedACR criteria.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=30 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=28 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX n=38 Participants Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX n=37 Participants Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Number of Subjects Meeting PedACR30 Response Criteria at the End of the Double-Blind Phase	17 Participants	9 Participants	24 Participants	14 Participants

SECONDARY outcome

Timeframe: Week 48

Responders met the following criteria: \>= 50% improvement in \>= 3 of 6 JIA core set criteria, and \>= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core variables are included in PedACR criteria.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=30 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=28 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX n=38 Participants Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX n=37 Participants Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Number of Subjects Meeting PedACR50 Response Criteria at the End of the Double-Blind Phase	16 Participants	9 Participants	24 Participants	14 Participants

SECONDARY outcome

Timeframe: Week 48

Responders met the following criteria: \>= 70% improvement in \>= 3 of 6 JIA core set criteria, and \>= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core variables are included in PedACR criteria.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=30 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=28 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX n=38 Participants Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX n=37 Participants Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Number of Subjects Meeting PedACR70 Response Criteria at the End of the Double-Blind Phase	14 Participants	8 Participants	24 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline and Week 48

Population: All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, who completed Week 48. Observed data of subjects who remained in the study at Week 48 were analyzed.

A 100 mm horizontal visual analog scale (VAS) was used to assess the Physician Global Assessment of Disease Activity. The left end of the VAS scale (0 mm) signified the absence of symptoms and the right end (100 mm) maximum disease activity. The mean change from open-label baseline to Week 48 was determined. Negative mean changes indicated improvement.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=17 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=9 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX n=24 Participants Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX n=15 Participants Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Mean Change From Baseline in Physician's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase	-52.06 Units on a scale Standard Error 3.713	-38.73 Units on a scale Standard Error 6.554	-48.50 Units on a scale Standard Error 3.890	-38.73 Units on a scale Standard Error 6.554

SECONDARY outcome

Timeframe: Baseline and Week 48

A 100 mm horizontal visual analog scale (VAS) was used to assess the Parent's/Patient's Global Assessment of Disease Activity. The left end of the VAS (0 mm) signified the absence of symptoms and the right end (100 mm) maximum disease activity. The mean change from open-label baseline to Week 48 was determined. Negative mean changes indicated improvement.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=17 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=9 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX n=24 Participants Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX n=15 Participants Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Mean Change From Baseline in Parent's/Patient's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase	-41.53 Units on a scale Standard Error 5.562	-50.56 Units on a scale Standard Error 6.129	-36.42 Units on a scale Standard Error 5.177	-26.87 Units on a scale Standard Error 5.644

SECONDARY outcome

Timeframe: Baseline and Week 48

Serum levels of C-reactive protein (CRP) were measured at screening (open-label baseline) and at Week 48. Negative mean changes in CRP from open-label baseline to Week 48 indicated improvement.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=17 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=9 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX n=24 Participants Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX n=15 Participants Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Mean Change From Baseline in C-Reactive Protein Levels at Week 48 of the Double-Blind Phase	-1.79 mg/dL Standard Error 0.803	-3.91 mg/dL Standard Error 2.000	-1.71 mg/dL Standard Error 0.529	-0.10 mg/dL Standard Error 0.333

SECONDARY outcome

Timeframe: Open-Label Lead-In Phase Baseline

Population: The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.

Responders met the following criteria: \>= 30%/50%/70% improvement in \>= 3 of 6 JIA core criteria, and \>= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=67 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=53 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Body Surface Area Phase PedACR30 Baseline	55 Participants	46 Participants	—	—
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Body Surface Area Phase PedACR50 Baseline	47 Participants	41 Participants	—	—
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Body Surface Area Phase PedACR70 Baseline	35 Participants	30 Participants	—	—

SECONDARY outcome

Timeframe: Week 56

Population: The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=55 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=41 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 56 of the Open-Label Extension Body Surface Area Phase PedACR30 Week 56	50 Participants	40 Participants	—	—
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 56 of the Open-Label Extension Body Surface Area Phase PedACR50 Week 56	49 Participants	40 Participants	—	—
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 56 of the Open-Label Extension Body Surface Area Phase PedACR70 Week 56	43 Participants	35 Participants	—	—

SECONDARY outcome

Timeframe: Week 104

Population: The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=19 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=17 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 104 of the Open-Label Extension Body Surface Area Phase PedACR30 Week 104	18 Participants	16 Participants	—	—
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 104 of the Open-Label Extension Body Surface Area Phase PedACR50 Week 104	16 Participants	16 Participants	—	—
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 104 of the Open-Label Extension Body Surface Area Phase PedACR70 Week 104	14 Participants	14 Participants	—	—

SECONDARY outcome

Timeframe: Baseline

Population: The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.

Responders met the following criteria: \>= 30%/50%/70% improvement in \>= 3 of 6 JIA core criteria, and \>= 30% worsening in not more than 1 JIA criterion, compared with OL-LI baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=53 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=45 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Fixed Dose Phase PedACR30 OLE FD Baseline	53 Participants	44 Participants	—	—
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Fixed Dose Phase PedACR50 OLE FD Baseline	50 Participants	43 Participants	—	—
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Fixed Dose Phase PedACR70 OLE FD Baseline	46 Participants	40 Participants	—	—

SECONDARY outcome

Timeframe: Week 48

Population: The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=51 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=40 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 48 of the Open-Label Extension Fixed Dose Phase PedACR30 Week 48	47 Participants	40 Participants	—	—
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 48 of the Open-Label Extension Fixed Dose Phase PedACR50 Week 48	47 Participants	39 Participants	—	—
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 48 of the Open-Label Extension Fixed Dose Phase PedACR70 Week 48	44 Participants	38 Participants	—	—

SECONDARY outcome

Timeframe: Week 112

Population: The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=41 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=31 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 112 of the Open-Label Extension Fixed Dose Phase PedACR30 Week 112	39 Participants	31 Participants	—	—
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 112 of the Open-Label Extension Fixed Dose Phase PedACR50 Week 112	39 Participants	30 Participants	—	—
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 112 of the Open-Label Extension Fixed Dose Phase PedACR70 Week 112	34 Participants	29 Participants	—	—

SECONDARY outcome

Timeframe: Final Visit (up to 224 weeks of OLE FD phase)

Population: The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.

Responders met the following criteria: \>= 30%/50%/70% improvement in \>= 3 of 6 JIA core criteria, and \>= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. Final Visit = last visit per subject (up to 224 weeks).

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=55 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=46 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Number of Subjects Meeting PedACR30/50/70 Response Criteria at the Final Visit (up to 224 Weeks) of the Open-Label Extension Fixed Dose Phase PedACR30 Final Visit	48 Participants	44 Participants	—	—
Number of Subjects Meeting PedACR30/50/70 Response Criteria at the Final Visit (up to 224 Weeks) of the Open-Label Extension Fixed Dose Phase PedACR50 Final Visit	45 Participants	43 Participants	—	—
Number of Subjects Meeting PedACR30/50/70 Response Criteria at the Final Visit (up to 224 Weeks) of the Open-Label Extension Fixed Dose Phase PedACR70 Final Visit	43 Participants	40 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline OLE BSA Phase

Gender (female/male) recorded at Baseline of the Open-Label Extension BSA phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section while including this phase of the study.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=71 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=57 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Baseline Measure: Gender, Female/Male - OLE BSA Phase OLE BSA Phase - Female	56 Participants	42 Participants	—	—
Baseline Measure: Gender, Female/Male - OLE BSA Phase OLE BSA Phase - Male	15 Participants	15 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline OLE BSA Phase

Age continuous (mean +/- SD) recorded at Baseline of the Open-Label Extension BSA phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section with this phase included.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=71 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=57 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Baseline Measure: Age Continuous - OLE BSA Phase	11.3 Years Standard Deviation 3.32	11.2 Years Standard Deviation 3.96	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline OLE FD Phase

Gender (female/male) recorded at Baseline of the Open-Label Extension FD phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section while including this phase of the study.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=59 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=47 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Baseline Measure: Gender, Female/Male - OLE FD Phase OLE FD Phase - Female	45 Participants	33 Participants	—	—
Baseline Measure: Gender, Female/Male - OLE FD Phase OLE FD Phase - Male	14 Participants	14 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline OLE FD Phase

Age continuous (mean +/- SD) recorded at Baseline of the Open-Label Extension FD phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section with this phase included.

Outcome measures

Outcome measures
Measure	Double-Blind Adalimumab n=59 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=47 Participants Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Adalimumab + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Placebo + MTX Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Baseline Measure: Age Continuous - OLE FD Phase	11.1 Years Standard Deviation 3.36	11.0 Years Standard Deviation 4.12	—	—

Adverse Events

Double-Blind Adalimumab + MTX

Serious events: 3 serious events

Other events: 27 other events

Deaths: 0 deaths

Double-Blind Placebo + MTX

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Double-Blind Adalimumab

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Double-Blind Placebo

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Open-Label Extension BSA Adalimumab + MTX

Serious events: 13 serious events

Other events: 62 other events

Deaths: 0 deaths

Open-Label Extension BSA Adalimumab

Serious events: 9 serious events

Other events: 46 other events

Deaths: 0 deaths

Open-Label Extension FD Adalimumab + MTX

Serious events: 7 serious events

Other events: 54 other events

Deaths: 0 deaths

Open-Label Extension FD Adalimumab

Serious events: 10 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Double-Blind Adalimumab + MTX n=38 participants at risk Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.	Double-Blind Placebo + MTX n=37 participants at risk Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.	Double-Blind Adalimumab n=30 participants at risk Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=28 participants at risk Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Open-Label Extension BSA Adalimumab + MTX n=71 participants at risk Subjects in the methotrexate (MTX) stratum received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow) concomitantly with MTX treatment during the Open-Label Extension BSA Phase of the study.	Open-Label Extension BSA Adalimumab n=57 participants at risk Subjects in the non-methotrexate (MTX) stratum received adalimumab (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose SC eow) without concomitant MTX treatment during the Open-Label Extension BSA Phase.	Open-Label Extension FD Adalimumab + MTX n=59 participants at risk Subjects in the methotrexate (MTX) stratum received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study, in which subjects were dosed based on body weight (not BSA). Subjects were separated into 2 body weight categories; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.	Open-Label Extension FD Adalimumab n=47 participants at risk Subjects in the methotrexate (MTX) stratum received adalimumab without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study, in which subjects were dosed based on body weight (not BSA). Subjects were separated into 2 body weight categories; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
Infections and infestations Bronchopneumonia	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.8% 1/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Herpes zoster	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.4% 1/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.8% 1/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Pharyngitis	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.4% 1/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Viral infection	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.4% 1/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.8% 1/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.8% 2/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.8% 4/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	14.9% 7/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Appendicitis	2.6% 1/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.4% 1/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.1% 1/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Gastrointestinal disorders Gastroduodenitis	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.7% 1/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Injury, poisoning and procedural complications Injury	2.6% 1/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Eye disorders Retinal detachment	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.7% 1/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Urinary tract infection	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.3% 1/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Gastrointestinal disorders Vomiting	2.6% 1/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Gastrointestinal disorders Abdominal pain	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.4% 1/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Gastrointestinal disorders Haematochezia	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.4% 1/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Gastrointestinal disorders Malabsorption	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.8% 1/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Musculoskeletal and connective tissue disorders Joint contracture	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.8% 1/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Musculoskeletal and connective tissue disorders Juvenile arthritis	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.0% 5/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.8% 1/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.7% 1/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.1% 1/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.4% 1/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Nervous system disorders Hydrocephalus	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.4% 1/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Nervous system disorders Speech disorder	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.8% 1/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Pregnancy, puerperium and perinatal conditions Abortion	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.8% 1/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.4% 1/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.5% 2/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.8% 1/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.4% 1/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.5% 2/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Cardiac disorders Pericarditis	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.1% 1/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Cervicitis	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.7% 1/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Investigations Laboratory test abnormal	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.7% 1/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.7% 1/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Musculoskeletal and connective tissue disorders Knee Deformity	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.7% 1/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.1% 1/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.1% 1/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.7% 1/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.1% 1/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.1% 1/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.7% 1/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.1% 1/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Psychiatric disorders Bipolar disorder	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.1% 1/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Psychiatric disorders Psychotic disorder	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.1% 1/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Reproductive system and breast disorders Breast enlargement	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.1% 1/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Skin and subcutaneous tissue disorders Acne	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.1% 1/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Surgical and medical procedures Abortion induced	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.7% 1/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.

Other adverse events

Other adverse events
Measure	Double-Blind Adalimumab + MTX n=38 participants at risk Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.	Double-Blind Placebo + MTX n=37 participants at risk Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.	Double-Blind Adalimumab n=30 participants at risk Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Double-Blind Placebo n=28 participants at risk Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Open-Label Extension BSA Adalimumab + MTX n=71 participants at risk Subjects in the methotrexate (MTX) stratum received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow) concomitantly with MTX treatment during the Open-Label Extension BSA Phase of the study.	Open-Label Extension BSA Adalimumab n=57 participants at risk Subjects in the non-methotrexate (MTX) stratum received adalimumab (24 mg/square meter of body surface area \[BSA\], up to a maximum of 40 mg total body dose SC eow) without concomitant MTX treatment during the Open-Label Extension BSA Phase.	Open-Label Extension FD Adalimumab + MTX n=59 participants at risk Subjects in the methotrexate (MTX) stratum received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study, in which subjects were dosed based on body weight (not BSA). Subjects were separated into 2 body weight categories; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.	Open-Label Extension FD Adalimumab n=47 participants at risk Subjects in the methotrexate (MTX) stratum received adalimumab without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study, in which subjects were dosed based on body weight (not BSA). Subjects were separated into 2 body weight categories; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
Injury, poisoning and procedural complications Arthropod bite	2.6% 1/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.7% 1/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.1% 2/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.6% 4/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.5% 2/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Respiratory, thoracic and mediastinal disorders Asthma	5.3% 2/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Injury, poisoning and procedural complications Blister	5.3% 2/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Injury, poisoning and procedural complications Contusion	18.4% 7/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	13.5% 5/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.7% 2/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.1% 2/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.6% 4/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.3% 3/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.7% 1/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	8.5% 4/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Respiratory, thoracic and mediastinal disorders Cough	5.3% 2/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.3% 1/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.6% 1/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	8.5% 6/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	8.8% 5/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Ear and labyrinth disorders Ear pain	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	10.0% 3/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Skin and subcutaneous tissue disorders Ecchymosis	5.3% 2/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.7% 1/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.1% 2/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Injury, poisoning and procedural complications Excoriation	10.5% 4/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.7% 1/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	10.0% 3/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.6% 1/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	9.9% 7/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.0% 4/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.4% 2/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	8.5% 4/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Nervous system disorders Headache	5.3% 2/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	8.1% 3/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.7% 2/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	14.3% 4/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	12.7% 9/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	14.0% 8/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.8% 4/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	23.4% 11/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Herpes simplex	2.6% 1/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.4% 2/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.3% 1/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Immune system disorders Hypersensitivity	5.3% 2/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.7% 2/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.4% 2/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.4% 3/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Impetigo	5.3% 2/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.3% 1/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.8% 2/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	8.8% 5/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Influenza	2.6% 1/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.7% 1/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.1% 2/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.8% 2/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.0% 4/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.1% 3/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	10.6% 5/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
General disorders Influenza like illness	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	10.8% 4/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.6% 4/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.8% 1/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
General disorders Injection site burning	2.6% 1/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.4% 2/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	13.3% 4/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
General disorders Injection site erythema	5.3% 2/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.7% 1/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.3% 1/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
General disorders Injection site pain	18.4% 7/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	16.2% 6/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	16.7% 5/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	10.7% 3/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	19.7% 14/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	17.5% 10/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.8% 4/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	8.5% 4/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
General disorders Injection site reaction	18.4% 7/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.7% 1/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	10.0% 3/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.6% 1/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	11.3% 8/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	15.8% 9/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Injury, poisoning and procedural complications Injury	5.3% 2/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.7% 1/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	10.7% 3/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.7% 1/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	8.5% 4/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Injury, poisoning and procedural complications Joint sprain	5.3% 2/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.1% 2/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.4% 1/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.0% 4/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Musculoskeletal and connective tissue disorders Juvenile arthritis	5.3% 2/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.7% 1/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.6% 1/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.8% 2/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.3% 3/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.8% 4/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	8.5% 4/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.7% 1/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.7% 2/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.6% 1/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.4% 1/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.0% 4/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Nasopharyngitis	13.2% 5/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	10.8% 4/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	10.7% 3/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	12.7% 9/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.0% 4/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	11.9% 7/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.4% 3/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
General disorders Pain	2.6% 1/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.7% 1/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	10.0% 3/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	10.7% 3/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.3% 3/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.4% 3/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.1% 2/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.6% 4/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Paronychia	2.6% 1/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.7% 2/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Pharyngitis	2.6% 1/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.4% 2/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.6% 1/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	12.7% 9/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.0% 4/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	10.2% 6/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.1% 1/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.1% 2/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
General disorders Pyrexia	5.3% 2/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.3% 1/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.6% 1/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.6% 4/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	10.5% 6/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.4% 2/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	10.6% 5/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Skin and subcutaneous tissue disorders Rash	2.6% 1/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.7% 1/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.7% 2/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.0% 5/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.0% 4/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.4% 2/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	12.8% 6/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Rhinitis	7.9% 3/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.7% 2/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.6% 4/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.5% 2/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.1% 3/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	8.5% 4/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Sinusitis	5.3% 2/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.6% 1/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	9.9% 7/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	12.3% 7/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	11.9% 7/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.4% 3/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Injury, poisoning and procedural complications Skin laceration	5.3% 2/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.3% 1/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	2.6% 1/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.3% 1/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.1% 2/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.8% 2/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.3% 3/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.4% 2/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.4% 3/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Injury, poisoning and procedural complications Thermal burn	2.6% 1/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	8.1% 3/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.6% 1/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Upper respiratory tract infection	13.2% 5/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	10.8% 4/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	20.0% 6/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	17.9% 5/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	29.6% 21/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	33.3% 19/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	25.4% 15/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	27.7% 13/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Viral infection	15.8% 6/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.4% 2/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	20.0% 6/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	10.7% 3/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	18.3% 13/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	15.8% 9/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	25.4% 15/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	17.0% 8/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Gastrointestinal disorders Vomiting	7.9% 3/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.4% 2/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.6% 1/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.0% 5/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.3% 3/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.4% 2/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.4% 3/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Eye disorders Conjunctivitis	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.0% 4/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Gastrointestinal disorders Nausea	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	12.7% 9/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.3% 3/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.4% 2/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	12.8% 6/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Bronchitis	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.6% 4/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.5% 2/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Ear infection	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.6% 4/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	11.9% 7/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.4% 3/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Gastroenteritis viral	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.1% 3/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.1% 1/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Otitis media	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.8% 2/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	8.8% 5/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.1% 3/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.1% 1/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Pharyngitis streptococcal	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	4.2% 3/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	10.5% 6/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.7% 1/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.4% 3/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Urinary tract infection	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.0% 5/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.0% 4/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	8.5% 5/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	4.3% 2/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	4.2% 3/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.0% 4/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	9.9% 7/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	12.3% 7/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	11.9% 7/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	12.8% 6/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.4% 1/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.3% 3/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	2.8% 2/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.3% 3/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.1% 3/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	8.5% 6/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.8% 4/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.0% 5/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.1% 3/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	8.5% 4/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	1.7% 1/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	8.5% 4/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
General disorders Fatigue	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.1% 3/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Oral herpes	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.1% 3/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Tonsillitis	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.1% 3/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	4.3% 2/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Investigations Blood triglycerides increased	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.1% 3/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	4.3% 2/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.4% 3/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.1% 3/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.8% 4/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	14.9% 7/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Gastrointestinal disorders Abdominal pain	0.00% 0/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.1% 2/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	8.5% 5/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	8.5% 4/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Skin and subcutaneous tissue disorders Acne	2.6% 1/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.7% 2/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	3.6% 1/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.1% 3/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	4.3% 2/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Infections and infestations Acute tonsillitis	2.6% 1/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.4% 2/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	5.6% 4/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	10.2% 6/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Musculoskeletal and connective tissue disorders Arthralgia	5.3% 2/38 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/37 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.7% 2/30 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	0.00% 0/28 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	7.0% 5/71 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	10.5% 6/57 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	6.8% 4/59 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.	14.9% 7/47 • DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.

Additional Information

Global Medical Services

Abbott

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
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Restriction type: OTHER