Statistical analysis
SECONDARY
A separate statistical analysis plan (SAP) has been produced which provides a more comprehensive description of the planned statistical analyses which is available from the corresponding author on request. The primary comparison groups will be composed of those treated with GH (25–35 μg/kg/day) versus those not treated with GH. Non-inferiority outcomes will be analysed using both intention-to-treat (ITT) (i.e. all participants will be analysed in the treatment group to which they were randomised, irrespective of compliance or other protocol deviation) and per-protocol analyses (i.e. those participants who are considered adherent to their allocated intervention, as defined in the SAP). This is because an ITT analysis alone may bias results in favour of non-inferiority. Superiority outcomes will be analysed using ITT analyses only. For all primary and secondary outcome measures, summary statistics and differences between groups will be presented with 95% confidence intervals. Outcomes will be adjusted for the minimisation variables and baseline values where appropriate. No adjustment for multiple comparisons will be made.