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Article History

Received: 6 August 2025

Accepted: 24 May 2026

First Online: 13 June 2026

Ethics

Declarations: Conflict of Interest J.E.H., D.I., A.L., M.E., L.E.K., D.G., S.J., K.E.P., P.S., H.-K.L., B.S., and T.N. are full-time employees of Pfizer, Inc., and own Pfizer stock. D.W. and J.W were full-time employees of Pfizer, Inc. at the time of conducting this analysis and may own Pfizer stock.

Availability of Data and Material: 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 participant data. See for more information. Model scripts may be made available upon reasonable request to the corresponding author.

Code Availability: Not applicable.

Ethics Approval: Each study site’s local independent ethics committee or institutional review board approved the study protocol. The study was conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. All patients provided written informed consent.

Consent to Participate: Written informed consent was obtained from all participants prior to study participation.

Consent for Publication: Not applicable.