While we saw a high placebo effect in the overall SAGA trial, we observed a considerably lower placebo effect in the 8-gene subset.
The decision to increase the sample size was made according to the protocol defined sample size re-estimatation design, which allows an adjustment in the sample size after an interim analysis of the placebo arm to ensure the trial is appropriately powered. As a result of the interim analysis performed by an independent unblinded statistician, the sample size will be increased from 42 to 64 patients.