Interim analysis
RECRUITMENT
In addition to the blinded sample size review to ensure that the trial achieves the required statistical power, there will be a single interim futility analysis for the primary outcome performed after the 18th month of recruitment (end of study month 25). At this point 6 months of 1-year follow-up data will be available. We anticipate at least 400 participants will have undergone 12-month follow-up for the primary outcome at this point and will be able to be analysed in this futility analysis.