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Robert Pickard, Beatriz Goulao, Sonya Carnell, Jing Shen, Graeme MacLennan, John Norrie, Matt Breckons, Luke Vale, Paul Whybrow, Tim Rapley, Rebecca Forbes, Stephanie Currer, Mark Forrest, Jennifer Wilkinson, Elaine McColl, Daniela Andrich, Stewart Barclay, Jonathan Cook, Anthony Mundy, James N’Dow, Stephen Payne & Nick Watkin.

Robert Pickard ^1,†, Beatriz Goulao ², Sonya Carnell ³, Jing Shen ⁴, Graeme MacLennan ⁵, John Norrie ⁶, Matt Breckons ⁴, Luke Vale ^4,*, Paul Whybrow ⁷, Tim Rapley ⁸, Rebecca Forbes ³, Stephanie Currer ³, Mark Forrest ⁵, Jennifer Wilkinson ³, Elaine McColl ⁴, Daniela Andrich ⁹, Stewart Barclay ¹⁰, Jonathan Cook ¹¹, Anthony Mundy ⁹, James N’Dow ¹², Stephen Payne ¹³, Nick Watkin ¹⁴

¹ Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK
² Health Services Research Unit, University of Aberdeen, Aberdeen, UK
³ Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK
⁴ Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK
⁵ Centre for Healthcare and Randomised Trials, University of Aberdeen, Aberdeen, UK
⁶ Usher Institute, University of Edinburgh, Edinburgh, UK
⁷ Hull York Medical School, Hull, UK
⁸ Social Work, Education & Community Wellbeing, University of Northumbria, Newcastle upon Tyne, UK
⁹ University College London Hospitals NHS Foundation Trust, London, UK
¹⁰ Patient representative, ,
¹¹ Oxford Clinical Trials Research Unit, Oxford University, Oxford, UK
¹² Academic Urology Unit, University of Aberdeen, Aberdeen, UK
¹³ Central Manchester Hospitals NHS Foundation Trust, Manchester, UK
¹⁴ St George’s University Hospitals NHS Foundation Trust, London, UK
^* Corresponding author Email: luke.vale@newcastle.ac.uk

^† In memoriam

In memoriam

Declared competing interests of authors: Robert Pickard, Graeme MacLennan, John Norrie, Luke Vale, Tim Rapley, Elaine McColl, Daniela Andrich and Jonathan Cook report grants from the NHS [National Institute for Health Research (NIHR)] during the conduct of the study. John Norrie reports membership of the following NIHR boards: Commissioning Priority Review Decision-making committee (2015); Health Technology Assessment (HTA) Commissioning Board (2010–16); HTA Commissioning Sub-Board (Expression of Interest) (2014); HTA Funding Boards Policy Group (2016–19); HTA General Board (2014–18); HTA Post-Board funding teleconference (2016–19); NIHR Clinical Trials Unit Standing Advisory Committee (2018–present); NIHR HTA and Efficacy and Mechanism Evaluation Editorial Board (2014–19); Pre-exposure Prophylaxis Impact Review Panel (2017). Luke Vale reports membership of NIHR HTA Clinical Evaluation and Trials panel from 2015 to March 2018. Elaine McColl reports grants from the NIHR Journals Library outside the submitted work. In addition, from 2013 to 2016 Elaine McColl was a member of the NIHR Journals Library Editorial Group. Jonathan Cook was a member of the HTA Efficient Study Designs Board (2014–16) during part of this study’s duration. James N’Dow was a member of the HTA General Board (2016 to March 2018).