Interim Analysis
ADVERSE EVENTS
The report of the interim analysis was received October 22, 2020, and included 84 patients, that is 13 patients more than the original planned analysis at 50% inclusion. The discrepancy was attributed to COVID-19. The interim analysis resulted in early termination of the study, as significantly more serious adverse events (SAEs) were reported in the experimental treatment group and there was low conditional power for any treatment benefit. The results presented here are from the final analysis of all randomized patients.