Stegwee, S. I.
Jordans, I. P. M.
van der Voet, L. F.
Bongers, M. Y.
de Groot, C. J. M.
Lambalk, C. B.
de Leeuw, R. A.
Hehenkamp, W. J. K.
van de Ven, P. M.
Bosmans, J. E.
Pajkrt, E.
Bakkum, E. A.
Radder, C. M.
Hemelaar, M.
van Baal, W. M.
Visser, H.
van Laar, J. O. E. H.
van Vliet, H. A. A. M.
Rijnders, R. J. P.
Sueters, M.
Janssen, C. A. H.
Hermes, W.
Feitsma, A. H.
Kapiteijn, K.
Scheepers, H. C. J.
Langenveld, J.
de Boer, K.
Coppus, S. F. P. J.
Schippers, D. H.
Oei, A. L. M.
Kaplan, M.
Papatsonis, D. N. M.
de Vleeschouwer, L. H. M.
van Beek, E.
Bekker, M. N.
Huisjes, A. J. M.
Meijer, W. J.
Deurloo, K. L.
Boormans, E. M. A.
van Eijndhoven, H. W. F.
Huirne, J. A. F.
Funding for this research was provided by:
ZonMw (80-84300-98-62021)
Article History
Received: 20 February 2018
Accepted: 12 February 2019
First Online: 4 March 2019
Ethics approval and consent to participate
: This study is approved by the ethics committee of Amsterdam UMC - location VUmc (reference number: 2015.462) and by the boards of all participating hospitals (Additional file InternalRef removed). Protocol amendments will be communicated to participating hospitals, after approval of the central MEC of Amsterdam UMC – location VUmc. This trial is registered in the Dutch Trial Register (NTR5480, ExternalRef removed). Counselling of eligible women will be done according to the ‘good clinical practice’ (GCP) guidelines or doctors certified according to Basic course Regulations and Organisation for Clinical researchers (BROK). After reading the patient information form and counselling by GCP- or BROK-certified personnel, women will be asked for written consent. This informed consent form will be obtained before participation in the clinical trial.The research team declares that the SPIRIT guidelines were followed. All recommended items of the SPIRIT 2013 checklist were addressed in this clinical trial protocol.The trial results will be communicated after the final inclusion and follow-up through publication in a peer-reviewed international journal and in an international congress. Participants will be informed through e-mail and the study website.
: Not applicable.
: All authors declare that they have no competing interests.
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