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Article History

Received: 2 February 2024

Accepted: 23 December 2024

First Online: 10 January 2025

Declarations

:

: The trial is being performed in accordance with the recommendations guiding physicians in biomedical research involving human subjects, adopted by the 18th World Medical Association General Assembly, Helsinki, Finland, 1964, amended by the 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996.The protocol (currently v4.0, dated 10-May-2023) was initially approved by the Yorkshire & The Humber—Leeds West Research Ethics Committee on 07-Jan-2022 (Ref. 21/YH/0300). Approval was also granted by the Medicines and Healthcare Products Regulatory Agency on 28-Jan-2022. The FEDORA Trial Office coordinates and communicates protocol modifications to all relevant parties.

: Not applicable.

: MFM has participated in advisory boards for Novartis, BMS, Incyte and GSK, and has received speakers bureau from Novatis, AOP Health, and Incyte. All other authors declare no competing interests.