Statistical analysis
PWS, rhGH initiation
All statistical analyses were performed using SAS version 9.4 (SAS Institute, Cary, NC, USA). The full analysis set (FAS) comprised all cases enrolled in the study who received the experimental drug at least once and had at least one post-drug assessment evaluated according to the intention-to-treat principle. All missing TMQ data in the FAS were imputed using the last-observation-carried forward method. The per-protocol set (PPS) was a subset of the FAS excluding subjects with major protocol violations. Safety data analyses were performed on a safety set (SS) that included all subjects who had received the study drug at least once and had post-drug safety evaluation data. Week 52 was the main evaluation time point, and all effects were compared before and after treatment within the group. Study results were further stratified by genetic subtype and age of rhGH initiation. The 9-month distinction for age of rhGH initiation was selected as it corresponds to the median age where children with PWS enter another nutritional phase [