According to PRCSG/PRINTO, disease flare defined as worsening of >=30 percent(%) in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. Six core variables: 1) Number of joints with active arthritis (joint with swelling/in absence of swelling, limited range of motion accompanied by pain/tenderness), 2)Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a Visual Analog Scale[VAS] of 0[no activity] to 10[maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0[very well] to 10[very poor], 5) Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI): 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score,which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) Erythrocyte Sedimentation Rate(ESR).

The Double Blind polyarticular course JIA analysis set (DBJAS) included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.

JIA ACR50 response defined as: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.

JIA ACR30 response defined as: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.

JIA ACR70 response defined as: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.

CHAQ is a valid assessment of functional disability, discomfort in participants with rheumatic diseases. It comprises of three indices: Disability and Discomfort, and global assessment of arthritis (overall well-being). CHAQ-DI: as a measure of functional ability, consists of 30 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed, among a total of 30 items. Each question was rated on a 4-point scale of difficulty in performance ranges from 0 (no difficulty) to 3 (unable to do). To calculate the overall score, the participant must have a domain score in at least 6 of the 8 domains. Scores of 8 domains were averaged to calculate the CHAQ-DI total score which ranges from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction), higher score indicates more disability. Change from double-blind baseline at Week 44 in DI total score is reported.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.

According to PRCSG/PRINTO, disease flare defined as worsening of >=30% in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. Six core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.

The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, 'number analyzed' (n) signifies participants evaluable for this outcome measure at specified time points.

According to PRCSG/PRINTO, disease flare defined as worsening of >=30% in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. Six core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.

Time to disease flare:time (in days) from first dose of study drug until the day of disease flare in open-label phase. According to PRCSG/PRINTO, disease flare: worsening of >=30% in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. 6 core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.

The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA.

Time to disease flare: time (in days) from first dose of study drug until the day of disease flare in double blind phase. According to PRCSG/PRINTO, disease flare: worsening of >=30% in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. 6 core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.

JIA ACR30 response defined as: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.

The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

JIA ACR30 response defined as: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.

JIA ACR50 response defined as: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.

The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

JIA ACR50 response defined as: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.

JIA ACR70 response defined as: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.

The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

JIA ACR70 response defined as: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.

JIA ACR90 response defined as: >=90% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.

The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here "n" signifies participants evaluable for this outcome measure at specified time points.

JIA ACR90 response defined as: >=90% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.

JIA ACR100 response defined as: >=100% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.

The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

JIA ACR100 response defined as: >=100% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.

JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease(defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.

The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease(defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in mg/L and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) ESR. The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.

The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) ESR. The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

Minimum Disease Activity is defined by a JADAS-27 CRP score less than or equal to 3.8 for participants with polyarthritis, and less than or equal to 2 for participants with oligoarthritis. JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease(maximum of 27 defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.

The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

Minimum Disease Activity is defined by a JADAS-27 CRP score less than or equal to 3.8 for participants with polyarthritis, and less than or equal to 2 for participants with oligoarthritis. JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.

JADAS-27 inactive disease is defined by a JADAS score less than or equal to 1. JADAS-27 Inactive Disease cutoff values are defined as: 1) Polyarthritis: Inactive Disease: <=1 and 2) Oligoarthritis (<4 active joints): Inactive Disease: <=1. JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.

The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

JADAS-27 inactive disease is defined by a JADAS score less than or equal to 1. JADAS-27 Inactive Disease cutoff values are defined as: 1) Polyarthritis: Inactive Disease: <=1 and 2) Oligoarthritis (<4 active joints): Inactive Disease: <=1. JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.

JIA ACR Inactive Disease criteria included: No joints with active arthritis, No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to sJIA, No active uveitis (as defined by the Standardized Uveitis Nomenclature (SUN) Working Group), Normal ESR (within normal limits of the method used where tested) or, if elevated, not attributable to JIA, Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]) score of 'best possible' (score of "0") on the scale used, morning stiffness of <=15 minutes.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

JIA ACR Clinical Remission Criteria included: Clinical inactive disease for 6 months continuously while on medications for JIA. Clinical Inactive Disease criteria included: No joints with active arthritis, No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to sJIA, No active uveitis (as defined by the SUN Working Group), Normal ESR (within normal limits of the method used where tested) or, if elevated, not attributable to JIA, Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]) score of 'best possible' (score of "0") on the scale used, morning stiffness of less than or equal to (<=) 15 minutes.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.

Number of joints with active arthritis defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness. The score range of the number of joints is from 0-71.

The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

Number of joints with active arthritis defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness. Number of joints ranged from 0 to 71.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

The maximum number of joints with limitation of movement was 67 and these were defined as those in the joint assessment with 'limitation of motion'.

The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

The maximum number of joints with limitation of movement was 67 and these were defined as those in the joint assessment with 'limitation of motion'.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

Physician global evaluation of disease activity was measured on a 21-numbered circle VAS ranges from 0 to 10 (in 0.5 increments), with '0' as 'No Activity' and '10' as 'Maximum Activity', higher score indicated more disease activity.

The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

Physician global evaluation of disease activity was measured on a 21-numbered circle VAS ranges from 0 to 10 (in 0.5 increments), with '0' as 'No Activity' and '10' as 'Maximum Activity', higher score indicated more disease activity.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

The parent/or legal guardian/participant rated the overall well-being on a 21-numbered circle VAS ranges from 0 to 10 (in 0.5 increments), with '0' as 'Very Well' and '10' as 'Very Poorly', higher scores=more disease activity.

The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

The parent/or legal guardian/participant rated the overall well-being on a 21-numbered circle VAS ranges from 0 to 10 (in 0.5 increments), with '0' as 'Very Well' and '10' as 'Very Poorly', higher scores=more disease activity.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

CHAQ is a valid assessment of functional disability, discomfort in participants with rheumatic diseases. It comprises of three indices: Disability and Discomfort, and global assessment of arthritis (overall well-being). CHAQ-DI: as a measure of functional ability, consists of 30 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed, among a total of 30 items. Each question was rated on a 4-point scale of difficulty in performance ranges from 0 (no difficulty) to 3 (unable to do). To calculate the overall score, the participant must have a domain score in at least 6 of the 8 domains. Scores of 8 domains were averaged to calculate the CHAQ-DI total score which ranges from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction), higher score indicates more disability. Change from baseline at Weeks 2, 4, 8, 12 and 18 in DI total score is reported.

The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

CHAQ: valid assessment of functional disability, discomfort in participants with rheumatic diseases. It comprises of three indices: Disability and Discomfort, and global assessment of arthritis (overall well-being). CHAQ-DI: as a measure of functional ability, consists of 30 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed, among a total of 30 items. Each question was rated on a 4-point scale of difficulty in performance ranges from 0 (no difficulty) to 3 (unable to do). To calculate overall score, participant must have a domain score in at least 6 of the 8 domains. Scores of 8 domains were averaged to calculate the CHAQ-DI total score which ranges from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction), higher score indicates more disability. Change from double-blind baseline at Weeks 20, 24, 28, 32, 36, and 40 in DI total score is reported.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

CHQ: 50-item, 14 subscale (Global health, physical functioning, social limitations: emotional, social limitations: physical, bodily pain, behavior, global behavior, mental health, self-esteem, general health, Change in health, emotional impact on parent, time impact on parent, family activities, family cohesion) parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents. Each subscale rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Two summary scores: Physical Health and Psychosocial Health were weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.

The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

CHQ: 50-item, 14 subscale (Global health, physical functioning, social limitations: emotional, social limitations: physical, bodily pain, behavior, global behavior, mental health, self-esteem, general health, Change in health, emotional impact on parent, time impact on parent, family activities, family cohesion) parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents. Each subscale rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Two summary scores: Physical Health and Psychosocial Health were weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

CHAQ is a validated instrument and comprises of two indices, Disability and Discomfort, and global assessment of arthritis (overall well-being). Discomfort Index included: assessment of discomfort, the parent/legal guardian/participant were asked to provide a response to the question: How much pain do you think your child had because of his or her illness in the past week?, The parent/legal guardian/ participant rated the overall pain on a 0 to 10 VAS, where '0' indicates 'No Pain' and '10' indicates 'Very Severe Pain', higher scores indicates more severity.

The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

CHAQ is a validated instrument and comprises of two indices, Disability and Discomfort, and global assessment of arthritis (overall well-being). Discomfort Index included: assessment of discomfort, the parent/legal guardian/participant were asked to provide a response to the question: How much pain do you think your child had because of his or her illness in the past week?, The parent/legal guardian/ participant rated the overall pain on a 0 to 10 VAS, where '0' indicates 'No Pain' and '10' indicates 'Very Severe Pain', higher scores indicates more severity.

The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

Uveitis is the inflammation of the uvea. Participants were assessed for presence of uveitis (according to Standard Uveitis Nomenclature [SUN]). If Uveitis was present in participant at Baseline, it was considered as "active uveitis"; If Uveitis was not present in participant at Baseline, it was considered as "Inactive uveitis". As per SUN, Uveitis is defined as: anterior (in which anterior chamber is primary site of inflammation); intermediate (primary site of inflammation: vitreous); posterior (primary site of inflammation: retina or choroid). Percentage of participants with active uveitis (of any type) are reported.

The OLFAS consists of all participants who were enrolled into open-label phase of the study and received at least one dose of study medication in open-label phase.

Uveitis is the inflammation of the uvea. Participants were assessed for presence of uveitis (according to Standard Uveitis Nomenclature [SUN]). If Uveitis was present in participant at Baseline, it was considered as "active uveitis"; If Uveitis was not present in participant at Baseline, it was considered as "Inactive uveitis". As per SUN, Uveitis is defined as: anterior (in which anterior chamber is primary site of inflammation); intermediate (primary site of inflammation: vitreous); posterior (primary site of inflammation: retina or choroid). Percentage of participants with active uveitis (of any type) are reported.

The double-blind safety analysis set (DBSAS) consists of all participants who have received at least one dose of study medication in double-blind phase.

Participants with enthesitis-related arthritis (ERA) undergo Tender entheseal assessment. Tender entheseal assessment: Entheses were assessed and coded as: 1= any tenderness, 0= no tenderness, NE= not evaluable. Total number of tender entheses: 66*(total number of tender entheses with counts > 0)/number of non-missing tender entheses. If > 33 tender entheseal counts were missing, total number of tender entheses was defined as missing.

OLERA included all participants who were enrolled into the open-label phase of study and received at least 1 dose of study medication in the open-label phase with ERA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

Participants with ERA undergo Tender entheseal assessment. Tender entheseal assessment: Entheses were assessed and coded as: 1= any tenderness, 0= no tenderness, NE= not evaluable. Total number of tender entheses: 66*(total number of tender entheses with counts > 0)/number of non-missing tender entheses. If > 33 tender entheseal counts were missing, total number of tender entheses was defined as missing.

DBERA included all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase with ERA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

Participants with ERA undergo Modified Schober's Test. In the Modified Schober's Test, a mark was placed 5 cm below the midpoint of a line that joined the posterior superior iliac spines. Another mark was placed 10 cm above the first. The participant then bent maximally forward with the knees fully extended. The distance between the two marks was then re-measured. The full measurement between the two lines was recorded to the nearest tenth of a centimeter and is reported.

OLERA included all participants who were enrolled into the open-label phase of study and received at least 1 dose of study medication in the open-label phase with ERA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

Participants with ERA undergo Modified Schober's Test. In the Modified Schober's Test, a mark was placed 5 cm below the midpoint of a line that joined the posterior superior iliac spines. Another mark was placed 10 cm above the first. The participant then bent maximally forward with the knees fully extended. The distance between the two marks was then re-measured. The full measurement between the two lines was recorded to the nearest tenth of a centimeter and is reported.

DBERA included all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase with ERA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

Participants with ERA undergo Overall Back Pain and Nocturnal Back Pain assessment. For Overall Back Pain, parent/legal guardian/participant were asked to provide a response to the question: What is the amount of back pain at any time that your child experienced in the past week? And For Nocturnal Back Pain: What is the amount of back pain at night that your child experienced in the past week?. Response to these questions was provided by parent/legal guardian/participant using a VAS of 0-10, where 0= No Pain and 10= Most Severe Pain, higher score indicated more severe pain.

OLERA included all participants who were enrolled into the open-label phase of study and received at least 1 dose of study medication in the open-label phase with ERA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

Participants with ERA undergo Overall Back Pain and Nocturnal Back Pain assessment. For Overall Back Pain, parent/legal guardian/participant were asked to provide a response to the question: What is the amount of back pain at any time that your child experienced in the past week? And For Nocturnal Back Pain: What is the amount of back pain at night that your child experienced in the past week?. Response to these questions was provided by parent/legal guardian/participant using a VAS of 0-10, where 0= No Pain and 10= Most Severe Pain, higher score indicated more severe pain.

DBERA included all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase with ERA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

Percentage of body surface area affected by psoriasis was estimated using the palm method. One of the participant's palm to proximal interphalangeal (PIP) and thumb =\together represented 1% of total BSA. Regions of the body were assigned specific number of palms with percentage (Head and Neck = 10% [10 palms], Upper extremities = 20% [20 palms], Trunk [axillae and groin] = 30% [30 palms], Lower extremities [buttocks] = 40% [40 palms]). The number of palms of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.

OLPsA (OL psoriatic arthritis PsA) included all participants who were enrolled into the open-label phase of study and received at least 1 dose of study medication in the open-label phase with PsA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

Percentage of body surface area affected by psoriasis was estimated using the palm method. One of the participant's palm to PIP and thumb together represented 1% of total BSA. Regions of the body were assigned specific number of palms with percentage (Head and Neck = 10% [10 palms], Upper extremities = 20% [20 palms], Trunk [axillae and groin] = 30% [30 palms], Lower extremities [buttocks] = 40% [40 palms]). The number of palms of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.

DBPsA included all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase with PsA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

The PGA of psoriasis was scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 5 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and ranged as 0= no symptom to 5=severe, higher score indicates more severity.

OLPsA included all participants who were enrolled into the open-label phase of study and received at least 1 dose of study medication in the open-label phase with PsA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

The PGA of psoriasis was scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 5 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and ranged as 0= no symptom to 5=severe, higher score indicates more severity.

DBPsA included all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase with PsA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

Oral solution was given only to participants weighing <40 kg and to the participants who were unable to swallow tablets. Taste assessment was evaluated using a 5 categories questionnaire. Participants were asked to answer in one of the following categories to describe the taste of oral solution of tofacitinib: dislike very much, dislike a little, not sure, like a little and like very much. Number of participants within each category are reported.

The OLFAS consists of all participants who were enrolled into open-label phase of the study and received at least one dose of study medication in open-label phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.

Serious infection defined as any infection that requires hospitalization for treatment or requires parenteral antimicrobial therapy or meets other criteria that require it to be classified as a serious adverse event. Cytopenia was categorized as: lymphocyte counts: <500 lymphocytes/ millimeter^3 (mm), neutrophil counts <1000 neutrophils/mm^3, platelet counts <100,000 platelets/mm^3, any single hemoglobin value <8 grams/decilitre (g/dL) and any single hemoglobin value drops >=2 g/dL below baseline. Number of Participants With serious infections, cytopenia, malignancies and Cardiovascular Diseases are reported.

The OLFAS consists of all participants who were enrolled into open-label phase of the study and received at least one dose of study medication in open-label phase.

Serious infection defined as any infection that requires hospitalization for treatment or requires parenteral antimicrobial therapy or meets other criteria that require it to be classified as a serious adverse event. Cytopenia was categorized as: lymphocyte counts <500 lymphocytes/mm^3, neutrophil counts <1000 neutrophils/mm^3, platelet counts <100000 platelets/mm^3, any single hemoglobin (hg) value <8 g/dL and any single hemoglobin value drops >=2 g/dL below baseline. Number of Participants With serious infections, cytopenia, malignancies and Cardiovascular Diseases are reported.

The DBFAS consists of all participants randomized to double-blind phase who received at least one dose of study medication in double-blind phase.

Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: no hair, Stage 2: downy hair, Stage 3: Scant terminal hair, Stage 4: Terminal hair that fills the entire triangle overlying the pubic region and Stage 5: Terminal hair that extends beyond the inguinal crease onto the thigh. Tanner Stage for pubic hair at Day 1 was summarized and reported using number of participants in each stage.

The OLFAS consists of all participants who were enrolled into open-label phase of the study and received at least one dose of study medication in open-label phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.

Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males) were assessed in this study and with values in the scale ranging from: Stage 1: no hair, Stage 2: downy hair, Stage 3: Scant terminal hair, Stage 4: Terminal hair that fills the entire triangle overlying the pubic region and Stage 5: Terminal hair that extends beyond the inguinal crease onto the thigh. Tanner Stage for pubic hair at Week 44 was summarized and reported using number of participants in each stage.

The double-blind safety analysis set (DBSAS) consists of all participants who have received at least one dose of study medication in double-blind phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.

Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: No glandular breast tissue palpable, Stage 2: Breast bud palpable under areola (1st pubertal sign in females), Stage 3: Breast tissue palpable outside areola; no areolar development, Stage 4: Areola elevated above contour of the breast, forming "double scoop" appearance, Stage 5: Areolar mound recedes back into single breast contour with areolar hyperpigmentation, papillae development and nipple protrusion. Tanner Stage for Breast at Day 1 was summarized and reported using number of participants in each stage.

The OLFAS consists of all participants who were enrolled into open-label phase of the study and received at least one dose of study medication in open-label phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.

Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: No glandular breast tissue palpable, Stage 2: Breast bud palpable under areola (1st pubertal sign in females), Stage 3: Breast tissue palpable outside areola; no areolar development, Stage 4: Areola elevated above contour of the breast, forming "double scoop" appearance, Stage 5: Areolar mound recedes back into single breast contour with areolar hyperpigmentation, papillae development and nipple protrusion. Tanner Stage for Breast at Week 44 was summarized and reported using number of participants in each stage.

The DBSAS consists of all participants who have received at least one dose of study medication in double-blind phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.

Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: Testicular volume < 4 ml or long axis < 2.5 cm, Stage 2: 4 ml-8 ml (or 2.5-3.3 cm long), 1st pubertal sign in males, Stage 3: 9 ml-12 ml (or 3.4-4.0 cm long), Stage 4: 15-20 ml (or 4.1-4.5 cm long), Stage 5: > 20 ml (or > 4.5 cm long). Tanner Stage for genitalia at Day 1 was summarized and reported using number of participants in each stage.

The OLFAS consists of all participants who were enrolled into open-label phase of the study and received at least one dose of study medication in open-label phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.

Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: Testicular volume < 4 ml or long axis < 2.5 cm, Stage 2: 4 ml-8 ml (or 2.5-3.3 cm long), 1st pubertal sign in males, Stage 3: 9 ml-12 ml (or 3.4-4.0 cm long), Stage 4: 15-20 ml (or 4.1-4.5 cm long), Stage 5: > 20 ml (or > 4.5 cm long). Tanner Stage for genitalia at Week 44 was summarized and reported using number of participants in each stage.

The DBSAS consists of all participants who have received atleast one dose of study medication in double-blind phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.

Criteria: Hemoglobin(Hg),hematocrit erythrocytes(Ery); <0.8*lower limit of normal (LLN), Ery. Mean Corpuscular Volume; <0.9*LLN, >1.1*upper limit of normal (ULN), Platelets; <0.5*LLN, >1.75*ULN, Leukocytes (leu); <0.6*LLN, >1.5*ULN, Lymphocytes (Ly), Ly/leu, Neutrophils, Neutrophils/leu <0.8*LLN, Basophils/leu, Eosinophils, Eosinophils/leu, Monocytes, Monocytes/leu >1.2*ULN, Ery Sedimentation Rate >1.5*ULN. Bilirubin, Indirect Bilirubin >1.5*ULN, AST, ALT, Gamma Glutamyl Transferase, Alkaline Phosphatase >3.0*ULN, Albumin >1.2*ULN, Creatinine >1.3*ULN, HDL Cholesterol (Chol)<0.8*LLN, LDL Chol, LDL Chol Friedewald Est PEG >1.2*ULN, Triglycerides >1.3*ULN, Calcium <0.9*LLN, Bicarbonate <0.9*LLN, Glucose >1.5*ULN, Creatine Kinase >2.0*ULN, C Reactive Protein >1.1*ULN, Chol >1.3*ULN. Urinalysis: Specific Gravity >1.030, Glucose, Ketones, Protein, Hg, Nitrite, Leu Esterase >=1, Ery, Leu >=20, Hyaline Casts >1.Only those category in which at least 1 participant had data is reported.

The OLFAS consists of all participants who were enrolled into open-label phase of the study and received at least one dose of study medication in open-label phase. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.

Criteria: Hg, hematocrit Ery; <0.8* LLN, Ery. Mean Corpuscular Volume; <0.9*LLN, >1.1* ULN, Platelets; <0.5*LLN, >1.75*ULN, leu; <0.6*LLN, >1.5*ULN, Ly, Ly/leu, Neutrophils, Neutrophils/leu <0.8*LLN, Basophils/leu, Eosinophils, Eosinophils/leu, Monocytes, Monocytes/leu >1.2*ULN, Prothrombin Time >1.1*ULN, Ery Sedimentation Rate >1.5*ULN. Bilirubin, Direct Bilirubin, Indirect Bilirubin >1.5*ULN, AST, ALT, Gamma Glutamyl Transferase (GGT), Alkaline Phosphatase >3.0*ULN, Albumin >1.2*ULN, Creatinine >1.3*ULN, HDL Cholesterol (Chol)<0.8*LLN, LDL Chol, LDL Chol Friedewald Est PEG >1.2*ULN, Triglycerides >1.3*ULN, Calcium <0.9*LLN, Bicarbonate <0.9*LLN, Glucose >1.5*ULN, Creatine Kinase >2.0*ULN, C Reactive Protein >1.1*ULN, Chol >1.3*ULN. Urinalysis: Specific Gravity >1.030, pH >8, urine Glucose, Ketones, Protein, Hg, Nitrite, Leu Esterase >=1, Ery, Leu >=20, Hyaline Casts >1.Only those category in which at least 1 participant had data is reported.

The DBSAS consists of all participants who have received atleast one dose of study medication in double-blind phase.

Physical examination included: abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, lymph nodes, neurological, nose, skin, and throat. Abnormality in physical examination was based on investigator's discretion.

The OLFAS consists of all participants who were enrolled into open-label phase of the study and received at least one dose of study medication in open-label phase. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.

Physical examination included: abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, lymph nodes, neurological, nose, skin, and throat. Abnormality in physical examination was based on investigator's discretion.

The DBSAS consists of all participants who have received at least one dose of study medication in double-blind phase. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.

Vital Sign Abnormalities criteria included: sitting diastolic blood pressure millimeters of Mercury (mmHG) of <50 mmHg, sitting pulse rate beats per minute (bpm) of <40 or 120 bpm, sitting systolic blood pressure (mmHG) of <90 mmHg, supine diastolic blood pressure (mmHG) of <50 mmHg, supine pulse rate (BPM) of <40 bpm or >120 bpm, supine systolic blood pressure (mmHG) of 90 mmHg.

The OLFAS consists of all participants who were enrolled into open-label phase of the study and received at least one dose of study medication in open-label phase. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.

Vital Sign Abnormalities criteria included: diastolic blood pressure (mmHG) of <50 mmHg, Pulse rate (BPM) of <40 bpm or >120 bpm, sitting diastolic blood pressure (mmHG) of <50 mmHg, sitting pulse rate beats per minute (bpm) of <40 bpm or >120 bpm, sitting systolic blood pressure (mmHG) of <90 mmHg, supine diastolic blood pressure (mmHG) of <50 mmHg, supine pulse rate (BPM) of <40 bpm or >120 bpm, supine systolic blood pressure (mmHG) of <90 mmHg, systolic blood pressure (mmHG) of <90 mmHg.

The DBSAS consists of all participants who have received atleast one dose of study medication in double-blind phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure and "n" signifies participants evaluable for this outcome measure at specified time points.

Change in vital Signs included: Sitting diastolic blood pressure [mmHG]: >=20mmHg increase from baseline (IFB) and >= 20mmHg decrease from baseline (DFB). Sitting systolic blood pressure mmHG: >= 30mmHg IFB and >= 30mmHg DFB. Supine diastolic blood pressure mmHG: >= 20mmHg IFB and >= 20mmHg DFB. Supine systolic blood pressure mmHG: >= 30mmHg IFB and >= 30mmHg DFB.

OLFAS: all participants who were enrolled into OL phase of study and received at least one dose of study medication in open-label phase.Here, 'n' signifies participants evaluable for this outcome measure at specified time points.

Change in vital Signs included: Sitting diastolic blood pressure (mmHG): >=20mmHg IFB and >= 20mmHg DFB. Sitting systolic blood pressure mmHG: >= 30mmHg IFB and >= 30mmHg DFB. Supine diastolic blood pressure mmHG: >= 20mmHg IFB and >= 20mmHg DFB. Supine systolic blood pressure mmHG: >= 30mmHg IFB and >= 30mmHg DFB.

The DBSAS consists of all participants who have received at least one dose of study medication in double-blind phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure and "n" signifies participants evaluable for this outcome measure at specified time points.