Haddadin, Yazan
Anagnostopoulou, Vasso
Bremner, Stephen
Harder, Helena
Starkings, Rachel
Lambert, Debbie
Porges, Alison
Perry, Nicky
Wood, Wendy
Arbon, Amy
Gage, Heather
Glover, Matthew
Macken, Lucia
Johnston, Malcolm
Ganai, Bhaskar
Joshi, Dhiraj
Hudson, Ben
Butler, Claire
Richardson, Alison
Wright, Mark
Prentice, Wendy
O’Brien, Alastair
Bedlington, Joan
Steer, Shani
Gaskin, Tom
Verma, Sumita https://orcid.org/0000-0001-7021-8409
Funding for this research was provided by:
Health Technology Assessment Programme (NIHR HTA 133889)
Article History
Received: 15 January 2025
Accepted: 9 May 2025
First Online: 4 June 2025
Declarations
:
: Protocol was approved by South Central–Oxford C Research Ethics Committee (22/SC/0164) on the 5th of August 2022. Written, informed consent to participate will be obtained from all participants. A model consent form is provided in Appendix 2. At the time of submission of study protocol for publication, no ancillary studies are planned, and consent will not be obtained for that potentiality. This applies to both optional research samples and the main consent forms covering clinical, health economics and patient-reported outcome data.
: Rocket Medical plc hold patient consent for Fig. 3 and gave permission for its use.
: SV: Rocket Medical plc and Becton Dickinson companies have supplied the LTADs free of cost. They have not been involved in development of the protocol, data collection, analysis or manuscript writeup. They will not claim Intellectual Property based on the trial. SV received research grants and consultancy from Gilead Sciences and speaker fees from Dr Falk. Other investigators: none declared.