Rans, Kato http://orcid.org/0000-0002-0389-4041
Charlien, Berghen
Filip, Ameye
Olivier, De Hertogh
Julie, den Hartog
Céderic, Draulans
Herlinde, Dumez
Benedikt, Engels
Karolien, Goffin
Annouschka, Laenen
Nick, Liefhooghe
Kenneth, Poels
Carl, Salembier
Koen, Slabbaert
Hans, Vandendriessche
Ben, Vanneste
Steven, Joniau
Gert, De Meerleer
Article History
Received: 3 August 2022
Accepted: 24 November 2022
First Online: 12 December 2022
Declarations
:
: Ethics approval was obtained by the Ethical Committee Research / KULeuven on March 24, 2022. A signed informed consent is required for all patients before inclusion in the study. The study is registered on Clinicaltrials.gov (NCT05352178). All personal data shall be treated as confidential at all times including during collection, handling and use or processing, and the personal data (including in any electronic format) shall be stored securely at all times and with all technical and organizational security measures necessary for compliance with EU and national data protection laws (whichever is more stringent). The Sponsor shall take appropriate steps to ensure the security of all personal data and guard against unauthorized access to or disclosure thereof or loss or destruction while in custody. The Sponsor is, even if there is no fault, liable for the damage suffered by the participant or in the event of death his/her beneficiaries and which is directly or indirectly related to his/her participation in the study. The participant does not have to demonstrate an error for this. The Sponsor has for this liability insurance. The Coordinating Investigator (CI) will fulfil his ethical obligation to disseminate and make the research results public. As such the CI is responsible for the timeliness, completeness and accuracy of the reports. Negative and inconclusive, as well as positive results will be published or otherwise made publicly available.
: Not applicable.
: The authors declare that they have no competing interests for this trial.