Statistical analyses

All randomized patients who received at least one dose of study medication formed the full analysis set for the intention to treat analyses. Patients were not censored at the time of allo SCT. Standard statistical methods were used for descriptive analyses. The Kaplan–Meier method and a stratified log-rank test for accounting for stratified randomization were used for unadjusted analyses of survival endpoints. Secondary multivariable analyses for survival outcomes were done using Cox regression models with likelihood-ratio tests for significance, adjusting for the influence of established prognostic parameters. Due to the longer follow-up, early censored observations were updated leading to slightly improved estimates compared to the earlier published results. Analyses were performed using SPSS version 20.0.0.1 and the software R version 3.1.1.

Informed consent was obtained from all patients according to the Declaration of Helsinki; the trial was approved by the responsible Ethics Committees of all participating sites, overseen by a data monitoring committee and registered on clinicaltrials.gov ({"type":"clinical-trial","attrs":{"text":"NCT00893373","term_id":"NCT00893373"}}NCT00893373) and in the EU Clinical Trials Register (2008-004968-40).