The standing height measurements were performed at the same time of the day by using a wallmounted device (e.g. Harpenden Stadiometer) at each study visit. The pre-specified clinical outcomes were analyzed at 12 and 24 months.

FAS. Number of Participants Analyzed = Number of children with evaluable height data at 12 and 24 months.

Percentage of children with serum IGF-1 > 2 SD (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment. 9 months and 12 months are combined.

The safety analysis set (SAS) was defined as all patients who received at least one dose of GH treatment. Number of Participants Analyzed = Number of children treated.

The height in SD was calculated using Sempe reference means and standard deviations for height. Change in height SD was calculated as height in SD at "12 months" minus height in SD at "Baseline".

The full analysis set (FAS) included all patients who received at least one dose of assigned treatment and had at least one subsequent rating of IGF-1. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD CA data at 12 months.

The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "24 months" minus height in SD at "Baseline".

FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD CA data at 24 months.

The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "12 or 24 months" minus height in SD at "Baseline".

FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable Height SD CA data at 12 and 24 months.

The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "12 months" minus height in SD at "Baseline".

FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD BA data at 12 months.

The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "24 months" minus height in SD at "Baseline".

FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD BA data at 24 months.

The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "12 or 24 months" minus height in SD at "Baseline".

FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 or 12 months with evaluable height SD BA data at 12 and 12 months.

Growth Rate was calculated at 12 months as:

(Height at 12 months minus Height at Day 0) divided by {(Date of 12 months minus Date of Day 0) divided by 365.25}

Growth Rate was calculated at 24 months as:

(Height at 24 months minus Height at 12 months) divided by {(Date of 24 months minus Date of 12 months) divided by 365.25}

FAS. Number of Participants Analyzed = Number of children treated. n = Number of children with evaluable growth rate data at 12 and 24 months.

Growth rate SD CA at 12 months was calculated as:(Growth rate at 12 months minus reference mean for CA at 12 months) divided by reference SD for CA at 12 months

Growth rate SD CA at 24 months was calculated as:(Growth rate at 24 months minus reference mean for CA at 24 months) divided by reference SD for CA at 24 months

FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD CA data at 12 months. n = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD CA data at 24 months.

Growth rate SD CA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for CA at 12 months) divided by reference SD for CA at 12 months

Growth rate SD CA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for CA at 24 months) divided by reference SD for CA at 24 months

FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable growth rate SD CA data at 12 and 24 months.

Growth rate SD BA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for BA at 12 months) divided by reference SD for BA at 12 months

FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD BA data at 12 months.

Growth rate SD BA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for BA at 24 months) divided by reference SD for BA at 24 months

FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD BA data at 24 months.

Growth rate SD BA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for BA at 12 months) divided by reference SD for CA at 12 months

Growth rate SD BA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for BA at 24 months) divided by reference SD for CA at 24 months

FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable growth rate SD BA data at 12 months. n = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable growth rate SD BA data at 24 months.

BMI was calculated at 12 months and 24 months as: (Weight at 12 or 24 months divided by Height at 12 or 24 months) squared

FAS. Number of Participants Analyzed = Number of children treated. n = Number of children with evaluable BMI data at 12 and 24 months.

Change in Height SD (CA) was calculated as:

Height SD (CA) at 12 months minus Height SD (CA) at Baseline

FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD CA data at 12 months.

Height SD (CA) at 24 months.

FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD CA data at 24 months.

Change in Height SD (BA) was calculated as:

Height SD (BA) at 12 months minus Height SD (BA) at Baseline

FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD BA data at 12 months.

Height SD (BA) at 24 months

FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD BA data at 24 months.

Change in BA was calculated as: (12 or 24 months minus Screening)

FAS. Number of Participants Analyzed = Number of children treated. n = Number of children with evaluable BA data at 12 and 24 months.

The BA/CA ratio was calculated at Screening, 12 and 24 months. The CA was the age on the date that the corresponding BA X-ray was performed.

FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable BA/CA data at 12 and 24 months.

The BA/CA ratio was calculated at Screening, 12 and 24 months. The CA was the age on the date that the corresponding BA X-ray was performed.

FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable BA/CA data at 12 and 24 months.

IGF-1 SD was calculated at each study time point using gender specific IGF-1 reference mean and SD for the CA of the child on the date of the corresponding IGF-1 blood sample: IGF-1 SD = (IGF-1 minus reference mean) divided by reference SD

SAS. Number of Participants Analyzed = Number of children treated. n = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable IGF-1 SD data at 6, 9, 12, 15, 18, 21, and 24 months.

IGF-1 SD was calculated at each study time point using these gender specific IGF-1 reference means and SDs for the CA of the child on the date of the corresponding IGF-1 blood sample: IGF-1 SD = (IGF-1 - reference mean) / reference SD

SAS. Number of Participants Analyzed = Number of children treated. n = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable IGF-1 SD data at 6, 9, 12, 15, 18, 21, and 24 months.

SAS. Number of Participants Analyzed = Number of children treated. n = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable IGF-1/IGFBP-3 data at 12 and 24 months.

SAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable IGF-1/IGFBP-3 data at 12 and 24 months.