Sensitivity analyses
A number of sensitivity analyses were conducted on the primary outcome. Treatment effects were also estimated using a linear mixed model with autoregressive correlation. Post-hoc sensitivity analyses used an autoregressive or exchangeable correlation structure with GEEs.
A further post-hoc sensitivity analysis was performed at all timepoints using the same analysis as the primary outcome. Since the intervention was only administered in a clinical setting, the outcome was whether a repeat infusion was administered or not; any participants who did not present for a follow-up appointment were coded as not having received a repeat infusion. Finally, the difference in proportions of participants who (1) received an infusion whether it was required or not and (2) received an infusion per protocol was analysed.
As a secondary post-hoc analysis, the primary outcome was estimated using all randomised participants to assess the possibility of bias and the effect of reduced power after ineligible participants were excluded.