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Article History

Received: 27 June 2025

Accepted: 29 September 2025

First Online: 12 October 2025

Declarations

:

: Jaydeep Mehta, Chuck Thompson, Ellen Scheers, Laurent Leclercq, Nahor Haddish-Berhane, Peter Hellemans, Juhui James Jiao, and Pamela L. Clemens are employees of and may hold stock in Johnson & Johnson. Seong Bok Jang and Dong Kyun Kim are employees of and may hold stock in Yuhan Corporation.

: The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at . As noted on this site, requests for access to the study data can be submitted through the Yale Open Data Access (YODA) Project site at .

: The NCT03556436 study was reviewed by an independent institutional review board (IRB), Seoul National University College of Medicine/Seoul National University Hospital, Seoul, South Korea (IRB approval number: H-1805-042-945). The NCT04410081 study was reviewed by independent IRB, BEBO Foundation, Assen, Netherlands (IRB approval number: NL74148.056.20). The NCT05076877 study was reviewed by independent IRB, Advarra, Maryland, USA (IRB approval number not applicable). All studies reporting data in human participants were conducted in accordance with Good Clinical Practice, the Declaration of Helsinki, and applicable regulatory requirements.

: Written informed consent was obtained for each participant.

: Not applicable.

: Not applicable.

: All authors were involved in the critical revisions of the manuscript and are accountable for all aspects of the work (accuracy and integrity), and approved the final manuscript submitted. JM, CT, ES, and LL contributed to the research conception and design; ES contributed to the provision of study materials; and JM, CT, ES, LL, SBJ, DKK, NHB, PH, JJJ, and PLC contributed to data collection, analysis, and interpretation.