Janssens, K. M. E. http://orcid.org/0000-0002-6625-3516
van Weeghel, J.
Henderson, C.
Joosen, M. C. W.
Brouwers, E. P. M.
Funding for this research was provided by:
ZonMw (535001003)
Article History
Received: 25 February 2020
Accepted: 5 May 2020
First Online: 29 May 2020
Ethics approval and consent to participate
: The Ethic Review Board of Tilburg University approved the study design, protocol, information letter, informed consent form and the questionnaires (EC-2018.06 t). The study is registered under trial registration number NL7798. Any changes to the protocol will be communicated to the funder and, if necessary, the Ethical Review Board will requested to approve amendments. If this is the case, the protocol will be updated in the clinical trial registry. Participation in the study is voluntary and all participants give signed informed consent for participation and publication of the results prior to participation to the study. There is no data monitoring committee installed; however, together with the ethical review proposal a data management plan has been prepared, which is part of the Research Data Management Policy of Tilburg University. This data management plan includes, for example, choices of software, hardware and accepted file formats; intellectual property rights and legal issues; selection of data and choice of the storage period and data management within the research group itself.
: Participants give signed informed consent for presentation of the results in publications and presentations.
: The author declares that there is no conflict of interest.