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Authors
Thomas, Rebecca https://orcid.org/0000-0003-2607-000X
Harman, Nicola L.
Williamson, Paula R.
Bonnett, Laura
Davies, Geraint R.
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Phillips, Patrick
Esmail, Hanif
Cirillo, Daniela
Dorman, Susan
Leinhardt, Christian
Stillo, Jonathan
Rucsineanu, Oxana
Kumar, Blessina
Tudor, Carrie
Rolfe, Katie
Chakaya, Jeremiah
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Funding
Funding for this research was provided by:
Innovative Medicines Initiative (101007873)
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Article History
Received: 18 March 2025
Accepted: 13 October 2025
First Online: 18 November 2025
Declarations
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: Ethics approval has been granted by the Institute of Population Health Research Ethics Committee (ref 12253). Written informed consent is a requirement for participant registration. The results of the Core Outcome Set (COS) process and recommendations will be shared with participants and stakeholder groups, including prominent clinical trial sponsors and networks, published in a peer-reviewed scientific manuscript, and disseminated at relevant international research meetings.
: Not applicable.
: The authors declare that they have no competing interests. All steering committee members and participants will be asked to declare any relevant conflicts of interest before participating in the process. No conflicts of interest have been made by members of the study steering committee that precludes further participation in the process.
