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Authors
Silversides, Jonathan A. https://orcid.org/0000-0002-9562-5462
Savic, Louise
Hiller, Louise
Hopkins, Amy
Booth, Katie
Dorey, Jennifer
Smithson, Richard
Mason, James
Frempong, Samuel
May, Christina
Moonesinghe, Ramani
O’Donnell, Ciara M.
Creagh-Brown, Benedict
Kandiyali, Rebecca
Yeung, Joyce
Pearse, Rupert
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Harris, Kirsten
McNeill, Hannah
Vass, David
Padfield, Emma
Kaur, Dalbir
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Funding
Funding for this research was provided by:
Health Technology Assessment Programme (NIHR133056)
Belfast Health and Social Care Trust
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Article History
Received: 26 May 2025
Accepted: 14 July 2025
First Online: 28 August 2025
Declarations
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: The trial will be conducted in full conformance with the principles of the Declaration of Helsinki and to ICH Good Clinical Practice (GCP) guidelines. It will also comply with all applicable UK legislation and the Standard Operating Procedures (SOPs) of the University of Warwick and the Sponsor (Belfast Health and Social Care Trust). Approvals for the trial were granted by the East Midlands Nottingham 2 Research Ethics Committee (22/EM/0231) on 12th January 2023, and by the Medicines and Healthcare Regulatory Authority (CTA 32485/0041/001–0001) on 20th Dec 2022. Before enrolling participants into the trial, each trial site must ensure that the local conduct of the trial has the agreement of the relevant NHS Trust Research & Development (R&D) department. Written, informed consent to participate will be obtained from all participants.
: Not applicable.
: RP is chair of the commissioning committee of the NIHR Health Technology Assessment programme. No other authors report competing interests.
