Failure-free survival. See “Methods” for the definition of failure. At 36 months the actuarial proportion of patients alive and failure-free was 72% (95% CI, 66%-78%) in the high-dose arm (HAD) and 74% (95% CI, 70%-78%) in the standard-dose arm (SDA). P = .66, log-rank test. The patients who dropped out or discontinued the treatment for AEs or SAEs were censored.