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Article History

Accepted: 15 August 2024

First Online: 11 September 2024

Declarations

:

: All clinical studies mentioned in this manuscript were funded by GSK.

: K.M.M. and S.Y. are employees of GSK and hold GSK shares. T.M.P., S.C.G., and E.M. are consultants at LAP&P, the Netherlands.

: All studies were conducted in accordance with the US Code of Federal Regulations (CFR), Good Clinical Practice, 21 CFR Parts 50, 56, and 312, the ethical principles set forth in the Declaration of Helsinki, the International Conference on Harmonization guideline regarding Good Clinical Practice (E6 Consolidated Guidance, April 1996), and the ethical requirements referred to in the European Union Directive 2001/20/EC. The study protocols were approved by the institutional review boards or ethics committees of the study sites.

: Informed consent was obtained from all individual participants included in the studies.

: Not applicable.

: Model code is available in Electronic Supplementary Materials

: All authors contributed to critically revising the manuscript for important intellectual content and approve the manuscript for publication.

: Please refer to GSK weblink to access GSK’s data sharing policies and as applicable seek anonymised subject level data via the link .