Randomisation	SA	ITT	FA	PP
Violation of major exclusion criteria	IV	IV	IV	IV	–
Violation of major exclusion criteria	CO	CO	CO	CO	–
Wrong treatment	IV	CO	IV	IV	–
Wrong treatment	CO	IV	CO	CO	–
Other major protocol deviation	IV	IV	IV	IV	–
Other major protocol deviation	CO	CO	CO	CO	–
No data for FU	IV	IV	IV	–	–
No data for FU	CO	CO	CO	–	–
None of above	IV	IV	IV	IV	IV
None of above	CO	CO	CO	CO	CO

SA Safety analysis set, ITT Intention-to-treat population, FA Full analysis set, PP Per-protocol population, IV and CO Randomised or analysed in the intervention and control group, respectively, “–” excluded from the analysis