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Dana Šumilo, Krishnarajah Nirantharakumar, Brian H Willis, Gavin M Rudge, James Martin, Krishna Gokhale, Rasiah Thayakaran, Nicola J Adderley, Joht Singh Chandan, Kelvin Okoth, Isobel M Harris, Ruth Hewston, Magdalena Skrybant, Jonathan J Deeks & Peter Brocklehurst.

Dana Šumilo ^1,2,*, Krishnarajah Nirantharakumar ^1,3, Brian H Willis ¹, Gavin M Rudge ¹, James Martin ¹, Krishna Gokhale ¹, Rasiah Thayakaran ¹, Nicola J Adderley ¹, Joht Singh Chandan ¹, Kelvin Okoth ¹, Isobel M Harris ¹, Ruth Hewston ⁴, Magdalena Skrybant ⁴, Jonathan J Deeks ^1,5, Peter Brocklehurst ¹

¹ Institute of Applied Health Research, University of Birmingham, Birmingham, UK
² Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK
³ Midlands Health Data Research UK, University of Birmingham, Birmingham, UK
⁴ Patient and public contributor, , UK
⁵ NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust, University of Birmingham, Birmingham, UK
^* Corresponding author Email: D.Sumilo@bham.ac.uk

Declared competing interests of authors: Krishnarajah Nirantharakumar reports grants from the Medical Research Council (MRC) (London, UK), National Institute for Health and Care Research (NIHR), Health Data Research UK (London, UK), AstraZeneca (Cambridge, UK), Vifor Pharma (Glattbrugg, Switzerland) and Action Against AMD (London, UK); grants and personal fees from Boehringer Ingelheim (Bracknell, UK); and personal fees from Sanofi SA (Paris, France) and Merck Sharp & Dohme (London, UK). He is also the director of OpenClinical.net and a trustee of the Network for Improving Critical care Systems and Training (Colombo, Sri Lanka) outside the submitted work. Magdalena Skrybant received grants from the NIHR Applied Research Collaboration West Midlands (Coventry, UK) during the conduct of the study. Jonathan J Deeks reports grants from the NIHR Health Technology Assessment (HTA) programme, during the conduct of the study. He is a former member of the HTA Medical Tests Methods Group, Pre-Exposure Prophylaxis Impact Review Panel, HTA Post-Funding Committee teleconference (POC members to attend), HTA Funding Committee Policy Group (formerly CSG), HTA Commissioning Committee, HTA Efficient Study Designs – 2, HTA Commissioning Committee and HTA End of Life Care and Add-on Studies. Peter Brocklehurst is a member of a Clinical Trials Unit funded by NIHR, a former member of HTA Efficient Study Designs – 2, the former chairperson of the HTA Maternal, Neonatal and Child Health Panel, an emeritus senior NIHR investigator and the former chairperson of MRC/NIHR Methodology Research Programme panel. He has received research grants as chief investigator from the NIHR HTA programme, the NIHR Efficacy and Mechanism Evaluation programme and the Wellcome Trust (London, UK), and consultancy fees from Biotest AG (Dreieich, Germany).