Christ, Carolien http://orcid.org/0000-0003-0604-551X
de Waal, Marleen M.
van Schaik, Digna J. F.
Kikkert, Martijn J.
Blankers, Matthijs
Bockting, Claudi L. H.
Beekman, Aartjan T. F.
Dekker, Jack J. M.
Funding for this research was provided by:
Nederlandse Organisatie voor Wetenschappelijk Onderzoek (432-13-811)
Article History
Received: 6 September 2017
Accepted: 17 January 2018
First Online: 2 February 2018
Ethics approval and consent to participate
: The study protocol has been reviewed and approved by the Medical Ethics Committee of the VU University Medical Center (registration number 2015.469). Participants will provide informed consent prior to enrollment in the study, and the informed consent form has been approved by the Medical Ethics Committee. The study is registered at the Netherlands Trial Register, part of the Dutch Cochrane Center (NTR5822). Approval for amendments to the protocol will be sought by the Ethics Committee, and will be updated in the Netherlands Trial Register. The study will be conducted in compliance with the Declaration of Helsinki and the Guidelines for Good Clinical Practice (GCP). The study protocol is in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.
: Not applicable.
: The authors declare that they have no competing interests.
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