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Authors
van Weert, E.
De Vuyst, HJ.
Van der Gucht, K.
Debbaut, E.
Steyaert, J.
Alaerts, K.
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Funding
Funding for this research was provided by:
Onderzoeksraad, KU Leuven (C2M/24/074, C2M/24/074, C2M/24/074, C2M/24/074, C2M/24/074, C2M/24/074)
Flanders Fund for Scientific Research (G018525N, G018525N, G018525N, G018525N, G018525N, G018525N)
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Article History
Received: 23 May 2025
Accepted: 4 June 2025
First Online: 1 July 2025
Declarations
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: This study was approved by Commissie Medische Ethiek AZ Delta of Belgium through the Clinical Trials Information System (CTIS) (EU CT number: 2024–513482-39–00). The protocol and informed consent forms adhere to the principles outlined in the latest version of the Declaration of Helsinki and the ICH-GCP E6(R2) guidelines. Any subsequent protocol amendments will be submitted for approval to the Competent Authority and Ethical Committee of Belgium.Written informed consent will be obtained from all participants by trained research staff before any study-related procedures. The consent process will include a verbal and written explanation of the study’s purpose, procedures, potential risks and benefits, and participants' rights, ensuring adequate time for questions. All trial staff involved in obtaining consent will be trained in Good Clinical Practice (GCP) and receive study-specific training before interacting with participants.
: Not applicable.
: The authors declare no competing interests.
