de Leeuwerk, Marijke http://orcid.org/0000-0003-3849-2605
de Groot, Vincent
Dam, Suzanne ten
Kruizenga, Hinke
Weijs, Peter
Geleijn, Edwin
van der Leeden, Marike
van der Schaaf, Marike
Dickhoff, Chris
Besselink, Marc G.
Tuynman, Jurriaan B.
van Berge Henegouwen, Mark I.
Erdmann, Joris I.
Huijsmans, Rosalie J.
van der Ploeg, Hidde P.
Eskes, Anne M.
Pijnappels, Mirjam A. G. M.
van Leeuwen, Liesbeth Schuijs
Smits, Anke B.
van Dijk, Jasmijn
Grimbergen, Eva
,
Funding for this research was provided by:
Amsterdam University Medical Centers
Article History
Received: 21 June 2023
Accepted: 5 October 2023
First Online: 27 November 2023
Declarations
:
: The trial protocol has been approved by the Medical Ethical Research Committee (METC) of Amsterdam UMC, location VUmc (METC 2021.0627). This study will be conducted according to the principles of the Declaration of Helsinki (version 9, October 2013), in accordance with the Dutch Medical Research Involving Human Subjects Act (WMO) and the Dutch Personal Data Protection Act (General Data Protection Regulation (GDPR)). The trial has been registered at the International Clinical Trials Registry Platform (NL9793) and the study description is available at the following web link: ExternalRef removed. All amendments of the protocol will be notified to the METC and the competent authority. Non-substantial amendments will not be notified to the accredited METC and the competent authority, but will be recorded and filed by the sponsor. Participating sites in the study will be notified of any changes to the study protocols. This will enable them to make the necessary arrangements to incorporate the changes, if necessary, and to confirm their continued support for the study after the implementation of the changes.All patients will sign informed consent prior to participation in the trial. All participants will be informed that they are under no obligation to enter the trial and that they can withdraw at any time during the trial without having to give a reason and that this will not affect the medical care they receive.
: Not applicable.
: The authors declare that they have no competing interests.