Box 11.

Exemplar on reporting item 6b

Example. Bayesian adaptive-enrichment AD; unplanned change from a secondary to a co-primary outcome, rationale, and when it happened “The second primary endpoint was the rate of functional independence (defined as a score of 0, 1, or 2 on the modified Rankin scale) at 90 days. This endpoint was changed from a secondary endpoint to a co-primary endpoint at the request of the Food and Drug Administration at 30 months after the start of the trial, when the trial was still blinded.” [96]