Interim Analysis
RECRUITMENT
Due to the unexpected additional risks to participating in this study due to the
COVID-19 pandemic, an unplanned interim futility/efficacy analysis of the
primary outcome measure was conducted after recruitment was halted in March
2020. Group labels were removed, and the analysis was reviewed by an independent
investigator. For the futility analysis, a conditional power of 20% was
selected. For the efficacy analysis, a 