Rangan, Amar http://orcid.org/0000-0002-5452-8578
Gwilym, Stephen
Keding, Ada
Corbacho, Belen
Kottam, Lucksy
Arundel, Catherine
Coleman, Elizabeth
DiMascio, Livio
Hewitt, Catherine
Jones, Valerie
Kassam, Jamila
McDaid, Catriona
Mitchell, Natasha
Mott, Andrew
O’Carroll, Grace
Tharmanathan, Puvan
Torgerson, David
Funding for this research was provided by:
Health Technology Assessment Programme (16/73/03)
Article History
Received: 23 February 2023
Accepted: 16 March 2023
First Online: 13 April 2023
Declarations
:
: Ethical approval for this trial has been granted by the North East - Tyne & Wear South REC. Reference number: 18/NE/0125 dated 2nd May 2018 (Additional file InternalRef removed), and HRA / HCRW dated 15th May 2018 (Additional file InternalRef removed). Before being enrolled in the PROFHER-2 study, participants must consent to participate after the nature, scope, and possible consequences of participating in the clinical study have been explained in a form understandable to them. The Investigator will not undertake any measures specifically required only for the clinical study until valid consent has been obtained. Written informed consent will be obtained from all participants. A copy of the PROFHER-2 consent form (v1.0 12.03.18, Additional file InternalRef removed) is provided as a supplement.
: Not applicable - no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. Informed consent materials are attached as supplementary materials - Additional file InternalRef removed.
: AR is a member of the NIHR i4i challenge awards committee and has received research and educational grants to his department from NIHR, ORUK, Horizon 2020, AOUK and DePuy J&J Ltd.CMcD is a member of the NIHR HTA and EME Editorial Board (2017 to present).