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The primary safety outcome was bleeding, either main or clinically relevant nonmajor bleeding. Major bleeding was thought as overt bleeding that was associated with a decrease in hemoglobin of at least 2 g per deciliter or that necessitated transfusion of 2 or more units of bloodstream, involved a crucial site , was disabling, required medical intervention, or contributed to loss of life. Bleeding episodes that did not meet the definition of major bleeding were regarded as clinically relevant only if they resulted in discontinuation of the study drug for more than 14 days. With programs developed a priori to subsequently pool the outcomes of the ASPIRE trial and the Warfarin and Aspirin trial,14 the protocols of both trials were prospectively harmonized to ensure that the randomized treatments were identical and that eligibility criteria and outcome definitions were comparable.