Wang, Ariel https://orcid.org/0000-0001-5360-9993
Seeley, Anna E https://orcid.org/0000-0001-5354-5889
Sydes, Matthew R https://orcid.org/0000-0002-9323-1371
Jones, Nicholas https://orcid.org/0000-0002-0352-3785
de Lusignan, Simon https://orcid.org/0000-0002-8553-2641
Hobbs, FD Richard https://orcid.org/0000-0001-7976-7172
McManus, Richard J https://orcid.org/0000-0003-3638-028X
Williams, Marney
Sheppard, James P https://orcid.org/0000-0002-4461-8756
Funding for this research was provided by:
National Institute for Health Research (NIHR) School for Primary Care (project 712)
Wellcome Trust/Royal Society via a Sir Henry Dale Fellowship (ref: 211182/Z/18/Z)
Article History
Received: 17 April 2025
Accepted: 26 May 2025
First Online: 7 June 2025
Declarations
:
: The OPTiMISE trial was approved by a National Health Service (NHS) Research Ethics Committee (South Central—Oxford A; 16/SC/0628) and the Medicines and Healthcare products Regulatory Agency (MHRA; 21584/0371/001–0001). All participants gave written informed consent. This study adhered to the Declaration of Helsinki.
: Not applicable.
: The authors declare no competing interests.
: Data sharing statement: Requests for sharing of de-identified individual participant data of the OPTiMISE trial and a data dictionary defining each field in the set will be considered by the corresponding author. The OPTiMISE study protocol is available on the trial website .