Mean levels of oestradiol in girls or testosterone in boys are reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.

A suppressed FSH response to the GnRH test was defined as a stimulated peak of FSH ≤3 IU/L. Percentage of patients who had a suppressed FSH response to the GnRH test is reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.

Mean changes of BMI from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.

Mean changes of BMI SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.

Mean changes of height SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.

Mean changes of growth velocity SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.

Mean changes of weight from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.

Mean change of predicted adult height SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented. Also note that data for this endpoint was analysed for girls only.

Mean change in difference between bone age and chronological age from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.

Percentage of girls who had a uterine length < 36 mm are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.

Pubic hair was measured by the Tanner method on a scale of 1 to 6. A low grade (i.e. 1) corresponds to a pre-pubertal stage and a high grade (i.e. 5 or 6) to an adult stage. Percentage of patients who had stabilisation or regression (no change in grade or a reduced grade) of Tanner pubic hair pubertal stage is reported. Study treatment was to last until the end of the therapeutic period; visits for Months 36 and 48 were optional because if the girl was already 11 and the boy already 13, they would have finished the study at a prior visit. The Final Visit was to occur only if the child did not end the study by a complete visit such as at Months 24, 36 or 48. Please also note the additional post-hoc analysis for percentage of children with a stabilisation or regression of Tanner pubic hair pubertal stage which applied the variable Last Visit on Treatment instead of Final Visit.

A suppressed LH response to the GnRH test was defined as a stimulated peak of LH ≤3 international units per litre (IU/L). Percentage of patients who had a suppressed LH response to the GnRH test is reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.

Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.

Mean levels of oestradiol in girls or testosterone in boys are reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.

Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.

A suppressed FSH response to the GnRH test was defined as a stimulated peak of FSH ≤3 IU/L. Percentage of patients who had a suppressed FSH response to the GnRH test is reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.

Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.

Mean changes of BMI from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.

Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.

Mean changes of BMI SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.

Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.

Mean changes of height SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.

Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.

Mean changes of growth velocity SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.

Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.

Mean changes of weight from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.

Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.

Mean change of predicted adult height SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented. Also note that data for this endpoint was analysed for girls only.

Analysis performed on female patients in the ITT population, consisting of all enrolled female patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.

Mean change in difference between bone age and chronological age from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.

Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.

Percentage of girls who had a uterine length < 36 mm are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.

Analysis performed on female patients in the ITT population, consisting of all enrolled female patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.

Pubic hair was measured by the Tanner method on a scale of 1 to 6. A low grade (i.e. 1) corresponds to a pre-pubertal stage and a high grade (i.e. 5 or 6) to an adult stage. Percentage of patients who had stabilisation or regression (no change in grade or a reduced grade) of Tanner pubic hair pubertal stage is reported. Study treatment was to last until the end of the therapeutic period; visits for Months 36 and 48 were optional because if the girl was already 11 and the boy already 13, they would have finished the study at a prior visit. The Final Visit was to occur only if the child did not end the study by a complete visit such as at Months 24, 36 or 48. Please also note the additional post-hoc analysis for percentage of children with a stabilisation or regression of Tanner pubic hair pubertal stage which applied the variable Last Visit on Treatment instead of Final Visit.

Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study.

One primary efficacy endpoint was to assess efficacy of triptorelin pamoate 11.25 mg with respect to percentage of girls maintaining a regression or stabilisation of sexual maturity (based on Tanner breast pubertal stage) until end of study. Results reported for this primary endpoint applied the variable 'Final Visit' for comparison to Pretreatment and Baseline. Since it was determined that the majority of patients had a Final Visit >3 months after their last injection, a post-hoc analysis of the percentage of girls with regression or stabilisation of Tanner breast pubertal stage was performed which applied the derived variable 'Last Visit on Treatment' to compare to the Pretreatment stage and to Baseline. This post-hoc analysis was judged to be appropriate since triptorelin pamoate 3-month formulation allows release of the active compound over 3 months and beyond this time, pubertal development is expected to progress.

Analysis performed on female patients in the ITT population, consisting of all enrolled female patients who received at least one injection of study treatment in this follow up study.

One secondary efficacy endpoint in this study was the percentage of children who had stabilisation or regression (no change in grade or a reduced grade) of Tanner pubic hair pubertal stage at the end of the study. Results reported for this secondary endpoint applied the variable 'Final Visit' for comparison to Pretreatment and Baseline. Since it was determined that the majority of patients had a Final Visit >3 months after their last injection, a post-hoc analysis of the percentage of children with regression or stabilisation of Tanner pubic hair pubertal stage was performed which applied the derived variable 'Last Visit on Treatment' for comparison to the Pretreatment stage. This post-hoc analysis was judged to be appropriate since triptorelin pamoate 3-month formulation allows release of the active compound over 3 months and beyond this time, pubertal development is expected to progress.

Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study.