Document is current

Article History

Accepted: 22 April 2025

First Online: 23 May 2025

Declarations

:

: This study was funded by Daiichi Sankyo, Inc.

: Yuan Xu, Mark Lee, Rujuta Joshi, Malaz Abutarif, Tushar Garimella, and Li Li are employees of and hold stock in Daiichi Sankyo. Xiaoning Wang was an employee of Metrum Research Group when the work was carried out. Hillary Husband, Rena Byrne, and Tim Waterhouse are employees of Metrum Research Group. Pavan Vaddady was an employee of Daiichi Sankyo when the work was carried out.

: Anonymized individual participant data (IPD) and applicable supporting clinical study documents may be made available upon request at . In cases where clinical study data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo Companies will continue to protect the privacy of the company and our clinical study subjects. Details on the data-sharing criteria and the procedure for requesting access can be found at: .

: Not applicable.

: Xiaoning Wang, Hillary Husband, and Rena Byrne analyzed the data. All authors made substantial contributions to the interpretation of the data and participated in drafting and critically revising the work. All authors approved the final version to be published and agree to be accountable for all aspects of the work.

: The study protocols were approved by the institutional review board for each institution and the studies were conducted in accordance with the ethical principles of the Declaration of Helsinki, the International Council for Harmonisation Guidelines for Good Clinical Practice, and local regulatory requirements.

: All patients provided written informed consent before participation in the studies.

: Not applicable.