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Article History

Received: 1 April 2025

Revised: 29 September 2025

Accepted: 17 October 2025

First Online: 6 November 2025

Competing interests

: JAD received funding from the National Institute for Health Research (NIHR) Senior Investigator Award (NIHR200274) and the NIHR Health Technology Assessment (HTA) grant (project reference 11/25/03) through the University of Warwick, which funded JAD, AM, AH and BS at the University of Warwick; CH, BS, and PSH at the University of Leeds. PSH received funding from NIHR, Lilly, Eisai, Novartis, Merck, Gilead, Sanofi, Roche, AstraZeneca, Novartis, AbbVie and SeaGen. DM received consultancy fees from Otsuka and Egetis. All other authors declared no conflict of interest in relation to this publication.

: The trial protocol and all amendments were approved by the UK Health Research Authority (West Midlands Research Ethics Committee 13/WM/0419). Potential participants were provided with a participant information sheet with details of the study and written informed consent (including consent for remote longer-term follow-up of deaths through NHS Digital) was obtained for the study before randomisation. An independent data monitoring board reviewed the accumulating data annually and reported recommendations to an independent steering committee, who provided oversight of the conduct of the trial. The protocol can be accessed online. The trial was registered with the ISRCTN registry, ISRCTN48534559. The study was performance in accordance with the Declaration of Helsinki.

: All authors consented to submit this manuscript for publication.