Ethics and dissemination

Ethics approval was obtained from each recruitment centre: (1) the Comité Ético de Investigación Clínica of Hospital 12 de Octubre, Madrid, Spain, on 22 February 2022 (Ref #22/027), and the study started recruitment on 1 March and (2) Southeast VI of Clermont Ferrand Hospital, France, on 5 September 2022 (Re# 22.01782.000095), and the study started recruitment on 5 December 2022. In Germany, the study has been authorised on 10 May 2023 by the competent authority, the national ‘Bundesinstitut für Arzneimittel und Medizinprodukte’ (BfArM), as meeting the expected legal requirements of a performance study in the scope of the regulation (EU) 2017/746 on in vitro diagnostic regulation.

This study’s results will be presented at national and international meetings, including meetings of patient associations, and published in peer-reviewed journals. There will be no notifications of individual results to the patients. All active collaborating investigators, research coordinators and institutions will receive credit from the main publications of the study under the name of BRAINI2 investigators.