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Jessica Harris 1, Koen B Pouwels 2, Thomas Johnson 3, Jonathan Sterne 4, Christalla Pithara 5, Kalaivani Mahadevan 3, Barney Reeves 1, Umberto Benedetto 6, Yoon Loke 7, Daniel Lasserson 8, Brett Doble 9, Noreen Hopewell-Kelly 10, Sabi Redwood 5, Sarah Wordsworth 2, Andrew Mumford 6, Chris Rogers 1, Maria Pufulete 1,*

1 Bristol Trials Centre, University of Bristol, Bristol, UK
2 Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK
3 Department of Cardiology, Bristol Heart Institute, Bristol, UK
4 National Institute for Health Research Biomedical Research Centre, Department of Population Health Sciences, University of Bristol, Bristol, UK
5 National Institute for Health Research Applied Research Collaboration West (NIHR ARC West), Bristol, UK
6 Bristol Medical School, University of Bristol, Bristol, UK
7 Norwich Medical School, University of East Anglia, Norwich, UK
8 Institute of Applied Health Research, University of Birmingham, Birmingham, UK
9 Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK
10 Health and Social Sciences, University of the West of England, Bristol, Bristol, UK
* Corresponding author Email: maria.pufulete@bristol.ac.uk

Declared competing interests of authors: Thomas Johnson reports grants, personal fees and meeting sponsorship from AstraZeneca plc (Cambridge, UK) and Bayer AG (Leverkusen, Germany); personal fees and meeting sponsorship from Daiichi Sankyo Company Ltd (Tokyo, Japan); and personal fees from The Medicines Company (London, UK), outside the submitted work. Thomas Johnson has also received honoraria or consultation fees from Abbott Laboratories (Abbott Park, IL, USA), Bayer AG, Biosensors International Group Ltd (Singapore), Boston Scientific (Marlborough, MA, USA), Medtronic plc (Dublin, Ireland), Terumo Corporation (Tokyo, Japan) and Vascular Perspectives Ltd (Holme, UK); grants from AstraZeneca plc and Bayer AG for research support; and sponsorship for a speakers’ bureau from Abbott Laboratories. Yoon Loke reports consultancy fees from Syri Ltd (Middlesex, UK) for regulatory review of drug treatments for peptic ulcer, outside the submitted work. Daniel Lasserson is a member of the Health Technology Assessment (HTA) Clinical Evaluation and Trials Committee (April 2016–July 2021). Chris Rogers is a member of the HTA Funding Committee Policy Group (2017–21) and the HTA Commissioning Committee (2016–21).

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