Flow diagram of the study. In total, 567 randomizations occurred in 469 patients. The ITT analysis set consisted of all transfusion-treatment periods in which the patient met the inclusion and exclusion criteria. In the event of >25% off-protocol transfusions or no transfusions, these episodes were analyzed “as randomized.” For the ITT analysis, the first day of observation was the day of randomization. The per-protocol set consisted of all “on-protocol” episodes (ie, episodes in which the percentage of off-protocol transfusions exceeded 25% before the first grade ≥2 bleeding event or episodes without transfusions were excluded). For the per-protocol analysis, the first day of observation was the day of the first platelet transfusion. The per-protocol–only analysis set consisted of all transfusion-treatment periods in which only on-protocol transfusions are administered before a grade ≥2 bleeding occurred; the first day of observation was the day of the first platelet transfusion.