Interim analysis and trial termination
RECRUITMENT, RECRUITMENT
Interim analyses, focused on safety and futility, were pre-specified by a DSMB charter to occur at the one-third and two-third enrolment benchmarks or every 6 months, whichever occurred first. Recruitment started in February 2018. Due to slow recruitment, the steering committee and DSMB agreed to decrease the statistical power from 90 to 80% in April 2019, lowering the intended sample size to 554 patients. Based on a subsequent pre-planned interim analyses conducted on October 31, 2019 (