CMV disease (right-censored for death) and the first event of CMV disease or death were defined as the clinical outcomes of interest. We performed surrogate analyses on the occurrence of these endpoints by time from randomization/treatment initiation rather than time from transplantation. Thus, whereas the original study (17) defined clinical endpoints at 100 and 180 days after HCT, we defined clinical endpoints for the surrogate analysis at weeks 8, 24, and 48 after randomization (Figure 1C). For the early treatment trial, week 8 after randomization was chosen as the first clinical outcome to approximate the RCT’s study endpoint because all of the clinical endpoints that occurred by 100 days after transplant had occurred by week 8 after randomization. For the prophylaxis trial, patients were randomized earlier (at engraftment rather than positive viral culture), and thus, week 14 (approximately 100 days after randomization) was chosen. For both studies, 24 and 48 weeks were chosen as later endpoints to approximate 180 days and 1 year after randomization.

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