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Article History

Received: 3 June 2021

Accepted: 1 February 2022

First Online: 22 February 2022

Declarations

:

: The study will be conducted in compliance with the principles of the Declaration of Helsinki (October 2013), and the principles of the Good Clinical Practices. The collection, processing, and disclosure of personal data, such as the health and medical information of participants, are subject to compliance with applicable personal data protection and the processing of personal data (Directive 95/46/EC and Belgian law of December 8, 1992, on the Protection of the Privacy in relation to the Processing of Personal Data). Approval of the Ethics Committee Research UZ/KU Leuven (S63018), as central ethics committee, and of the Comité Medische Ethiek Ziekenhuis Oost-Limburg (ctu2019088 and EC19/0096L), Commissie Medische Ethiek Noorderhart Mariaziekenhuis (S63018), Commissie medische ethiek AZ Groeninge (AZGS2020051), Commissie Medische Ethiek GZA (201106ACADEM), Commissie Medische Ethiek Imeldaziekenhuis (S63018), Ethisch comité Regional Hospital Heilig Hart Tienen (B322201942452), Commissie Medische Ethiek AZ Sint-Lucas Gent (2020–42), Comité d'Ethique Centre Hospitalier de Wallonie picarde (P2020-013) was obtained before the start of the study in each respective participating site. The study is also preregistered on ClinicalTrials.gov: NCT04747860. All participants provided written informed consent to participate in the study.

: Not applicable.

: The authors declare that they have no competing interests.