Statistical analysis
REGRESSION, SECONDARY
Statistical analyses were performed using SAS version 9.4 (SAS Inc., Cary, NC, USA). Primary and secondary non-safety endpoints were evaluated using the per-protocol population of all randomised patients, excluding patients with no baseline and/or on-treatment value and important protocol deviations leading to exclusion. Safety analyses used all randomised patients who received trial treatment. The dose–response relationship of the primary endpoint was analysed using a nonlinear regression model (decreasing Emax curve) applied to the AOC3 activity at Week 12. The fitted regression model was used to derive the smallest dose where the mean plasma AOC3 activity curve dropped below 10%. For the secondary biomarker endpoints, the MMRM was used to generate adjusted mean and 90% CI estimates for the treatment effects at Week 12. These estimates, together with the corresponding covariance matrix, were used to analyse the dose–response relationship by examining the fit of eight shapes modelled using MCPMod