Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH <4 IU/L. Peak stimulated LH refers to the maximum LH concentration measured 30 minutes after a gonadotropin-releasing hormone agonst (GnRHa) stimulation test.

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.

Percentage of subjects with suppressed serum LH concentrations(<4 IU/L) 30 minutes post GnRHa stimulation test at all assessed timepoints.

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.

Changes in height velocity (growth rate) at all study timepoints after Screening to end of study. Growth velocity is defined for each visit as change from baseline / [(number of weeks since baseline)/52]. Week 48: Change from Week 24 growth velocity is defined as change from week 24 to week 48 / [(number of weeks since week 24)/52].

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.

Bone Age Ratio to Chronological Age at Time of Measurement is bone age/age at bone age assessment.

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.

The percent change from baseline in height at each available post-baseline measurement. Percent change is defined as (((change from Baseline)/(Baseline)) x 100).

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.

Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.

Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.

Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.

Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.

Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.

Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing. Tanner Stages: I (<10yrs), II (10-11yrs), III (11-13yrs), IV (13-14yrs), V (>14yrs).

Height at each available measurement point. Baseline is defined as the last non-missing height measurement collected prior to or on the date of first injection.

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.

Bone Age at each available measurement point.

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.

Bone age progression at each available post-baseline measurement point. Bone age progression is defined as (((change from baseline)/(baseline)) x 100), which is percent change from baseline.

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.

Bone Age Ratio to Chronological Age at Time of Measurement is bone age/age at bone age assessment.

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.

Bone age advancement was evaluated relative to chronological age at each given measurement point. Percent change from baseline is: 100 x (the change from baseline value at the post-baseline visit / baseline value).

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.

Bone age advancement was evaluated relative to chronological age at each given measurement point. Bone Age Ratio to Chronological Age at Start of Study is bone age/age at first injection.

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.

GnRH Antagonist Evaluation occurred for the two week period following each treatment and at each visit to assess flare symptoms. The percent of subjects who affirm (or whose parent/guardian affirms) each symptom domain in the global interview.

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.

The percentage of subjects with FSH, estradiol and testosterone suppression to prepubertal levels (FSH < 2.5 mIU/mL, estradiol < 20 pg/mL and testosterone < 28.4 ng/dL) at each available time point.

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.

Changes in ratio of LH/FSH at each time point from Screening to End of Study

Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.