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Article History

Received: 5 May 2025

Accepted: 5 October 2025

First Online: 28 October 2025

Change Date: 24 November 2025

Change Type: Update

Change Details: The original online version of this article was revised: A typo in the second point of the key points "United States" has been corrected.

Declarations

:

: HC, SR, SH, BVH, VS, MJ, TB, EA, SDC, JHL: Employee: Johnson & Johnson; Shareholder: Johnson & Johnson.

: All studies included in these analyses were conducted in accordance with the ethical principles originating in the Declaration of Helsinki, International Council for Harmonisation (ICH) Good Clinical Practice guidelines, and applicable regulatory requirements and in compliance with the respective protocols. The studies were approved by an independent ethics committee or institutional review board at each participating site. Ethics committee approval was obtained for all original studies included in these analyses, and detailed information is available in their respective publications [ – ].

: Adult participants signed a written consent form. For participants under the age of 18 years, parents or a legal guardian provided written informed consent and participants provided written age-appropriate assent prior to the conduct of study assessments, examinations, or procedures.

: Not applicable.

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

: Not applicable.

: Study design: JHL. Analyzing data: HC, JHL, VS, BvH. Interpreting data: HC, SDC, TB, JHL, SR, SH, BVH, MJ, EA. Writing/revising the manuscript: HC, SDC, TB, JHL, VS, SR, SH, BVH, MJ, EA. All authors read and approved the final version of the manuscript.