Height velocity (HV) was derived from height measurements taken at baseline (week 0) and the week 26 as: HV = (height at 26 weeks visit- height at baseline) / (time from baseline to 26 weeks visit in years).

FAS was used to analyse this outcome measure. FAS is defined as all randomized participants that received at least one dose of randomized treatment. Here, Overall number of participants analysed = participants with available data for this outcome measure.

Change in height standard deviation score is presented from baseline (week 0) to end of the main trial period week 26 and end of extension trial period week 52. The formula to calculate HSDS is: HSDS = ((Height / M)**L-1) / (L*S). L: The gender and age-specific power in the Box-Cox transformation, M: The gender and age-specific median, S: The gender and age-specific generalized coefficient of variation. The range for HSDS was -10 to +10. Negative scores indicated a height below the mean height for a child with the same age and gender, whereas positive scores indicated a height above the mean height for a child with the same age and gender.

This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomised participants that received at least one dose of randomised treatment. Here, Overall number of participants analysed = participants with available data for this outcome measure.

Change in height velocity standard deviation score is presented from baseline (week 0) to end of main trial period week 26 and end of extension trial period week 52. HVSDS was calculated using the formula: HVSDS = (height velocity - mean)/standard deviation (SD), where height velocity was the height velocity variable measured, mean and SD of height velocity by gender and age for the reference population. The range for HVSDS was -10 to +10. Negative scores indicated a height velocity below the mean height velocity for a child with the same age and gender, whereas positive scores indicated a height velocity above the mean height velocity for a child with the same age and gender.

This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomised participants that received at least one dose of randomised treatment. Here, Overall number of participants analysed = participants with available data for this outcome measure.

Adverse events per 100 patient years are presented. AEs with an onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up until visit 32 (week 364) or 14 days after last trial drug administration, which ever comes first, for all other participants, are analysed.

Safety analysis set (SAS) is defined as all randomised participants that received at least one dose of randomised treatment. Data for 3 somapacitan arms (0.04/0.08/0.16 mg/kg) have been pooled from week 156-364, because it was considered appropriate to pool the data from those arms since the size of each individual cohort was small and it would give a more robust measure of long-term safety and tolerability of treatment with somapacitan 0.16 mg/kg/week using this methodology.

Participants who developed anti-NNC0195-0092 and anti-hGH antibodies are reported in this outcome measure.

This outcome measure was assessed only for Cohort 1 and SAS was used to analyse this outcome measure. SAS is defined as all randomized participants that received at least one dose of randomized treatment.

Participants who were randomised to somapacitan 0.04/0.08/0.16 mg/kg/week) received respective doses from week 0 to week 52. From week 52 to week 364, all randomised participants received open labelled somapacitan 0.16 mg/kg/week.

Change in IGF-I SDS is presented from baseline (week 0) to end of main trial period week 26 and end of extension period week 52. The range for IGF-I SDS was from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender.

This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomised participants that received at least one dose of randomised treatment. Here, Overall number of participants analysed = participants with available data for this outcome measure. Number analysed = participants analysed for specific category for this outcome measure.

Change in IGFBP-3 SDS is presented from baseline (week 0) to end of main trial period week 26 and end of extension trial period week 52. The range for IGFBP-3 SDS was from -10 to +10. Negative scores indicated a IGFBP-3 below the mean IGFBP-3 for a child with the same age and gender, whereas positive scores indicated a IGFBP-3 above the mean IGFBP-3 for a child with the same age and gender.

This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomised participants that received at least one dose of randomised treatment. Here, Overall number of participants analysed = participants with available data for this outcome measure. Number analysed = participants analysed for specific category for this outcome measure.

This primary outcome measure was analysed by cohort using descriptive statistics. Adverse event per 100 patient years are presented in this outcome measure.

The outcome measure was assessed only for Cohort II and Cohort III. All participants: all adverse events (AEs) with an onset after the first administration of trial product & up until 14 days after last trial drug administration for withdrawn participants, & with an onset after the first administration of trial product & up until visit 32 (week 208) or 14 days after last trial drug administration, which ever comes first for all participants are included in the analysis.

HV was derived from height measurements taken at baseline (week 0) and the week 52 as: HV = (height at 52 weeks visit-height at baseline) / (time from baseline to 52 weeks visit in years)

This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomized participants that received at least one dose of randomized treatment. Here, Overall number of participants analysed = participants with available data for this outcome measure.

The bone age vs. chronological age ratio is presented at week 52. X-Ray of left hand and wrist, central assessed according to Greulich & Pyle atlas were taken.

This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomized participants that received at least one dose of randomized treatment. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.

Serum somapacitan concentrations are presented at week 52.

This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomized participants that received at least one dose of randomized treatment. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.

Change in Treatment Related Impact Measure from baseline (week 0) to week 26 and week 52 were assessed in children with growth hormone deficiency. This outcome measure was assessed using patient reported outcome (PRO) questionnaires with 3 domains, such as emotional well-being score, physical health score, social wellbeing core and total score. The total score was calculated by taking average of each domain. The scale range for each domain and total score was from 0-100 and a lower score indicates a better health state. TRIMCGHD-O was analysed using descriptive statistics.

This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomized participants that received at least one dose of randomized treatment. Here, Overall number of participants analysed = participants with available data for this outcome measure. Number analysed = participants analysed for specific category for this outcome measure.

Total score of Treatment Burden Measure (observer) was assessed at week 26 and at week 52 in children with growth hormone deficiency. This outcome measure was assessed using PRO questionnaires. The scale range for total score was from 0-100 and a lower score indicates a better health state.

This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomized participants that received at least one dose of randomized treatment. Here, Overall number of participants analysed = participants with available data for this outcome measure. Number analysed = participants analysed for specific category for this outcome measure.

Total score of Treatment Burden Measure (parent/guardian) is reported at week 26 and at week 52 in children with growth hormone deficiency. This outcome measure was assessed using PRO questionnaires. The scale range for total score was from 0-100 and a lower score indicates a better health state.

This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomized participants that received at least one dose of randomized treatment. Here, Overall number of participants analysed = participants with available data for this outcome measure. Number analysed = participants analysed for specific category for this outcome measure.