Table 4

ITT and per-protocol analyses

PFSFFSEFSOSATFS
ITT principle (ITT population, whatever the treatment) +++ − − +++ − 
Per-protocol analyses      
    Within the ITT population, and according to study therapy Optional Optional 
    Within subgroups   Optional   
PFSFFSEFSOSATFS
ITT principle (ITT population, whatever the treatment) +++ − − +++ − 
Per-protocol analyses      
    Within the ITT population, and according to study therapy Optional Optional 
    Within subgroups   Optional   

Optional indicates that these analyses are not recommended by ELN (if these analyses are required in some studies, reasons and definitions have to be explicitly provided) +++, highly recommended; +, to be considered; and −, not relevant, based on ELN definitions.

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