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Authors
de Rijk, Florence E. M. https://orcid.org/0000-0002-5315-2230
van Veldhuisen, Charlotte L.
Besselink, Marc G.
van Hooft, Jeanin E.
van Santvoort, Hjalmar C.
van Geenen, Erwin J. M.
van Werkhoven, Cornelis H.
de Jonge, Pieter Jan F.
Bruno, Marco J.
Verdonk, Robert C.
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Funding
Funding for this research was provided by:
Mylan
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Article History
Received: 2 June 2022
Accepted: 19 December 2022
First Online: 7 January 2023
Declarations
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: This trial is conducted according to the principles of the 2013 Declaration of Helsinki and in accordance with the ICH guidelines for Good Clinical Practice. The need for ethical approval was waived by the Medical Ethics Committees United (MEC-U). In addition, local board approval was obtained from all the participating hospitals. Patients are preferably recruited by the local principal investigators. If this is not possible for logistic reasons, a designated substitute (the study coordinator, local treating physicians or a study nurse) who is fully informed and aware of the study procedures and requirements will replace the local principal investigator. Written informed consent is obtained from each participant. Patients are subsequently asked whether or not they would like to be contacted for future follow-up studies when signing the informed consent form to participate in this trial.
: Not applicable, the study results will not contain any data from any individual person.
: The authors declare that they have no competing interests.
