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Article History

Accepted: 4 August 2025

First Online: 19 August 2025

Declarations

:

: This study was funded by Pfizer.

: M.E., P.S., J.H., O.A., D.W., and H.L. report employment and stock ownership at Pfizer.

: Upon request and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual de-identified patient data. See for more information.

: The study was conducted in accordance with the ethics principles of the Declaration of Helsinki and the Council for International Organizations of Medical Sciences International Ethical Guidelines, and the International Council for Harmonization Good Clinical Practice Guidelines. All relevant documents, including amendments, were reviewed and approved by the institutional review board and/or ethics committee of each participating center.

: All patients provided written informed consent.

: Not applicable.

: Not applicable.

: All authors were involved in the trial conception/design, or the acquisition, analysis, or interpretation of data. All authors contributed to the drafting of the manuscript and approved the final version.