Gompelman, Michelle http://orcid.org/0000-0002-8568-5437
Wouters, Yannick
Kievit, Wietske
Hopman, Joost
Wertheim, Heiman F.
Bleeker-Rovers, Chantal P.
Wanten, Geert J. A.
Funding for this research was provided by:
ZonMw (848015009)
Innovatiefonds Zorgverzekeraars (3536)
Article History
Received: 14 March 2018
Accepted: 8 June 2018
First Online: 28 June 2018
Ethics approval and consent to participate
: The CARRIER trial will be conducted according to the principles of the Declaration of Helsinki (7th version, October 2013) and the Dutch Medical Research Involving Human Subjects Act. The medical ethics review committee of the Radboudumc (CMO Nijmegen-Arnhem) has approved the trial protocol (NL61885.091.17). According to Dutch law, ethical approval by the ethics review board of the study sponsor (i.e., initiating center, Radboudumc, Nijmegen, the Netherlands) is mandatory. All substantial protocol modifications will be notified as protocol amendments to this committee. Before participation, all participants are required to provide their written informed consent, which will be re-confirmed at each stage by the research team.
: Not applicable.
: The authors declare that they have no competing interests.
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