Minimum detectable effect size for main outcomes (accounting for sample
design and clustering)
With 2,000 analyzed individuals, equal assignment, a two-sided alpha of 0.05, and 80 percent power, the approximate unadjusted minimum detectable effect is 0.125 standard deviations for a continuous outcome and 6.3 percentage points for a binary outcome with a control mean of 0.50. If 80 percent of baseline completers provide the day-14 outcome, analyzed N is approximately 1,600 and the corresponding unadjusted continuous-outcome MDE is approximately 0.140 standard deviations. If only 80 percent belong to the confirmatory population and 80 percent of that group respond, analyzed N is approximately 1,280 and the MDE is approximately 0.157 standard deviations, or 7.8 percentage points for a binary outcome with a 0.50 control mean.