Witte, Jan A. http://orcid.org/0000-0002-9037-1002
Braunstahl, Gert-Jan
Blox, Wouter J. B.
van ’t Westeinde, Susan C.
in ’t Veen, Johannes C. C. M.
Kappen, Jasper H.
van Rossum, Elisabeth F. C.
Funding for this research was provided by:
stichting beterketen
stichting o&o franciscus gasthuis & vlietland
Article History
Received: 4 August 2021
Accepted: 26 January 2022
First Online: 5 February 2022
Declarations
:
: The study is designed according to the principles of the Declaration of Helsinki (7th revision, October 2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO) and other guidelines, regulations and Acts such as Good Clinical Practice. Written informed consent will be obtained by a GCP-certified researcher at the first study visit. The Medical Research Ethics Committees United (MEC-U, Nieuwegein, The Netherlands) gave a waiver with reference number R20.062. The Dutch Competent Authority (Bevoegde Instantie, CCMO) approved the study with protocol ID NL73155.100.20. Amendments to the protocol have to be approved by both the Ethics Committee and the Dutch Competent Authority. Amendments need approval of the Ethics committee, the Dutch Competent Authority and the study sites representative before implementation.
: Not applicable.
: The before named authors report no conflict of interest.