Before revision: Inclusion and exclusion criteria are meant ot ensure patients safety during the study, provide data (justification) of subject appropriateness for the study, to minimize withdrawl (also costs) and ensure that primary end-points of study are reached.
After revision: Inclusion and exclusion criteria are meant to ensure patients safety during the study, provide data (justification) of subject appropriateness for the study, to minimize withdrawl (also costs) and ensure that primary end-points of study are reached.