Interim analyses
One month after the first 100 participants are enrolled, an interim analysis will be held by the independent statistician of the trial. Data will be exported independently from all sites and then data collated and merged for the interim analysis. The above-described statistical analysis will be evaluated as well as safety profile. Enrollment is expected to occur within the first 2 months of launch. Interim analysis will occur based on study enrollment, and three to six interim analyses will occur based on temporal dynamics of enrollment as requested by the DSMB. We will stop the clinical trial early if the 