Study endpoints and statistical analysis
SECONDARY
The primary endpoint was the incidence of CIOM during autologous HSCT according to acyclovir prophylaxis. The secondary endpoint was the incidence of HSV reactivation during autologous HSCT according to acyclovir prophylaxis and the association between oral HSV reactivation and CIOM. The intent-to-treat analysis was planned for all randomized patients. The per-protocol analysis was planned for subjects who completed the study without a protocol violation.Considering the results of previous studies [Demographic data are expressed as the mean, median, standard deviation, maximum, and minimum for continuous variables, and the frequency and ratio are summarized for categorical variables. Analyses were primarily performed for all subjects randomized in the study, but additional per-protocol analyses were also conducted from subjects who fully complied with the intervention. The association between two independent variables was analyzed through Fisher’s exact test or the chi-square test, where appropriate. Continuous variables were analyzed by t test or Wilcoxon’s signed rank test paired according to normality assumption satisfaction, and categorical variables were analyzed by McNemar test.