It was not set up as an adaptive trial, but the trial has been modified along the way to reduce some of the exclusion criteria and speed enrollment, while maintaining a population of very severe/critical patients.

The clinical trials site does not address the 195 interim analysis, but that has been included in PRs from Cytodyn for months.

My understanding is that the interim analysis, above and beyond DSMC safety evaluations, need to be specified at the time of trial design and approval.