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Article History

Received: 4 April 2025

Accepted: 10 November 2025

First Online: 1 December 2025

Declarations

:

: Yasmin Sánchez-Pearson, Jennifer Moore (at time of study conduct), Jerzy Daniluk, Sookti Bhangu, Prosenjit Sarkar (at time of study conduct), Alicia Aylott, Farai Moyo, Amanda Peppercorn and Andrew Skingsley are employed by and hold financial equities in GSK. Sergio Parra and Asma El Zailik (at time of study conduct) are employed by and hold stocks/shares in Vir Biotechnology, Inc™.

: This study was conducted in accordance with the protocol and consensus ethical principles derived from international guidelines including the Declaration of Helsinki, Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable International Council for Harmonisation (ICH) Good Clinical Practice Guidelines, US 21 Code of Federal Regulations (CFR) 312.120, and other applicable laws and regulations. Participants and/or their legally authorised representative were informed that their participation was voluntary. Participants or their legally authorised representative were required to sign a statement of informed consent that met the requirements of 21 CFR 50, local regulations, ICH guidelines, and the Health Insurance Portability and Accountability Act requirements, where applicable, and the institutional review boards and ethics committees or study centre.

: Written informed consent was obtained from each participant prior to the performance of any study-specific procedures. Each participant was provided with as much time as necessary to review the informed consent form, to inquire about details of the trial and to decide whether to participate in the study.

: Not applicable.

: Anonymised individual participant data and study documents can be requested for further research from .

: Not applicable.

: Study conception/design: YSP, JM, JD, SP, AEZ, PS, AA, FM, AP, AS. Data acquisition: YSP, JM, JD, SB, SP, AEZ, PS, AA, FM, AP, AS. Data analysis and interpretation: YSP, JM, JD, SP, AEZ, PS, AA, FM, AP, AS. All authors took part in drafting, revising or critically reviewing the manuscript; read and approved the final version of the manuscript; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.