Document is current

Article History

Received: 13 May 2025

Accepted: 8 October 2025

First Online: 4 November 2025

Declarations

:

: The trial was performed in accordance with the recommendations guiding physicians in biomedical research involving human subjects adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964, amended at the 52nd World Medical Association General Assembly, Edinburgh, Scotland, (2013). Informed written consent was obtained from the patients prior to randomisation into the study, with the right of a participant to refuse participation without giving reasons. The participant had the right to withdraw at any time from the study without giving reasons and without prejudicing his/her further treatment. The study was submitted to and approved by a main REC and the appropriate Site-Specific Assessor for each participating centre prior to entering patients into the study. The trial protocol, the written informed consent form, and other materials related to the participants were approved by the ethics committees at all sites [ ]. The ethics committee(s) for respective participating countries were as follows: UK: NHS Health Research Authority, London Bridge Research Ethics Committee. Ireland: Ethics & Medical Research Department, St Vincent’s University Hospital, Dublin. Italy: Comitato Etico dell’Area Vasta Emilia Nord; Comitato Etico Fondazione Policlinico Universitario Agostino Gemelli IRCCS Università Cattolica del Sacro Cuore. Germany: Ethikkommission bei der Medizinischen Fakultät der LMU München; Ethikkommission der Medizinischen Fakultät der Universität zu Köln. Poland: Niezależna Komisja Bioetyczna ds. Badań Naukowych, Gdański Uniwersytet Medyczny. Australia: Western Sydney Local Health District Human Research Ethics Committee, Westmead, NSW. New Zealand: Health and Disability Ethics Committees, Ministry of Health, Wellington, NZ.

: N/A.

: The authors declare no competing interests.