Interim analysis

Last week, the 6th of February 2025, participant no 1250 was randomized at Cardiff University Hospital UK, and triggered the next interim analysis. This means that on the 8th of March 2025, 30 days will have elapsed since this randomization. We would like to allow one additional month for data completion for all participants, before delivering data to the Data Safety Monitoring Committee (DSMC) for the second interim report.  

Therefore the 8th April 2025 is the proposed last day of data entry of all patients randomized in the trial up until the 6th of February 2025. 

Please do not forget to register also complications, 30-day outcome, and 6-month outcome for those who have passed that time point. The data completeness looks very good so far, but please try to be meticulous with these last data points. Please let us know if this data entry may be challenging for your site.