Document is current

Article History

Received: 18 June 2020

Accepted: 7 July 2020

First Online: 17 August 2020

Ethics approval and consent to participate

: This study will be conducted as part of the portfolio of trials in the registered UKCRC Oxford Clinical Trials Research Unit (OCTRU) at the University of Oxford. It will follow their Standard Operating Procedures ensuring compliance with the principles of Good Clinical Practice and the Declaration of Helsinki and any applicable regulatory requirements. The final version of this study protocol was approved by the London – Brent Research Ethics Committee (20/HRA/2105) on 5 May 2020. The local ethics committees will be given access to original records and databases. The chief investigator (Timothy SC Hinks) certifies that this trial has received ethical approval from the London – Brent Research Ethics Committee. Written informed consent will be required prior to inclusion.

: “Not applicable”.

: TSCH has received grants from Pfizer Inc., grants from University of Oxford, grants from the Wellcome Trust, grants from The Guardians of the Beit Fellowship and grants from the NIHR Oxford Biomedical Research Centre during the conduct of the study and personal fees from Astra Zeneca, personal fees from TEVA and personal fees from Peer Voice outside the submitted work.MJ has received grants from the University of Oxford and NIHR Oxford Biomedical Research Centre.DR has undertaken paid consultancy for GSK outside the submitted work.IDP reports personal fees from AstraZeneca, Boehringer Ingelheim, Aerocrine, Almirall, Novartis, GlaxoSmithKline, Genentech, Regeneron, Teva, Chiesi, Sanofi, Circassia and Knopp and grants from NIHR outside the submitted work.MB reports grants from AZ and personal fees and non-financial support from AZ, Chiesi, GSK and others from AlbusHealth, outside the submitted work.DL, JM, NJM, VSB, SJD and JB declare they have no competing interests.