Statistics and reproducibility
death
EVENT
The analysis of the primary endpoint was done via a log-rank test, stratified for the factor ‘patient group’. The event ‘death from any cause’ was handled by censoring those patients at day 84 (ref. All findings, including clinical and laboratory data, were documented by the investigator or an authorized member of the study team in the patient’s medical record and in the electronic case report forms (ClinCase Software Version 2.7.0.3). A responsible monitor checked all flagged data and generated questions that were sent back to the responsible investigator. The investigator had to resolve all discrepancies. Further checks for plausibility, consistency and completeness of data were performed after completion of the study. Statistical analyses were performed using the software packages SAS version 9.4, R Base (version 4.0; 