Received: 17 October 2022
Accepted: 21 November 2022
First Online: 9 December 2022
: The trial, as conducted in accordance with the Declaration of Helsinki, was approved by the institutional review board or independent ethics committee at each center, and all subjects provided informed consent.
: Not applicable.
: Donald Berry and Scott Berry are co-owners of Berry Consultants, LLC, a company that designs Bayesian adaptive clinical trials for pharmaceutical and medical device companies, NIH cooperative groups, international consortia, and patient advocacy groups. Eisai Inc. is a client of Berry Consultants.Shobha Dhadda, Michio Kanekiyo, David Li, Chad J. Swanson, Michael Irizarry, and Lynn D. Kramer are employees of Eisai Inc.