Analyses performed on:

• Intention to Treat (ITT): all patients having received ≥1 injection. Any subject with missing data is considered a non-responder.
• Modified ITT (mITT): all ITT patients with ≥ Month 3 post-baseline assessment of primary efficacy criterion.
• Per Protocol (PP): all mITT patients without major protocol deviations.

Analysis was performed on Intention to Treat population (ITT) defined as all participants having received at least one injection of 11.25 mg triptorelin pamoate. "n" indicates the number of patients who had an assessment at the visit.

Analysis was performed on the ITT population. 3 participants and 2 participants had missing data at month 3 and month 6 respectively.

Analysis was performed on the ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 and 3 participants had missing data at month 2 and month 5 respectively.

Analysis was performed on ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 and 3 participants had missing data at month 2 and month 5 respectively.

Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 participant and 3 participants had missing data at month 2 and 5 respectively.

Testosterone level from the male patient in the ITT population.

Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 3 and month 6.

Pubertal stage (graded from 1 to 5 for penis and breast development, graded from 1 to 6 for pubic hair development) according to the Tanner method was collected. A low stage (i.e. 1) corresponds to a pre-pubertal stage and a high stage (i.e. 5 or 6) to an adult stage. Any increase of grade was defined as 'increased' and no change in grade or a reduced grade was defined as 'stabilised or reduced'.

Analysis was performed on the ITT population. 2 participants had missing data for pubic hair stage and breast stage.

Standard deviation (SD) is a standard term used in growth studies and represents Standard Deviations calculated as the patient value minus the mean divided by the standard deviation. Standard Deviation Scores vary depending on the age and sex of the child.

Analysis was performed on the ITT population. 2 participants had missing data at month 6.

Analysis was performed on the ITT population. 1 and 2 participants had missing data at month 0 and month 6 respectively.

Change from baseline of GV was calculated as: GV at month 6 - GV at baseline. GV SDS was calculated using SAS algorithm.

Growth velocity during the study was calculated using the two height measures as: GV = (Height at baseline - Height at screening)*365/delay between two height measures.

Analysis was performed on the ITT population. If GV at screening was missing, the value was derived from data recorded between 5 to 19 months ago otherwise GV at screening was considered missing. 9 participants had missing data.

Bone age was defined according to Greulich and Pyle method. Chronological age was calculated using the date of birth.

Analysis was performed on the ITT population. 33 participants were assessed. 4 participants had missing data at month 6.

Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 3 and 6.

Analysis was performed on the Pharmacokinetics (PK) Valid population defined as all participants who received at least one injection of 11.25 mg triptorelin pamoate and had at least one PK assessment. 2 participants had data missing at month 1,3 and 6. 1, 3 and 4 participants had data missing at month 2, 4 and 5 respectively.