van Ravenhorst, Mariëtte B.
van der Klis, Fiona R. M.
van Rooijen, Debbie M.
Sanders, Elisabeth A. M.
Berbers, Guy A. M.
Article History
Received: 14 November 2017
Accepted: 20 December 2018
First Online: 5 January 2019
Ethics approval and consent to participate
: Ethical approval was obtained from the local Medical research Ethics Committees United (MEC-U). The trial was undertaken in accordance with the Good Clinical Practice guidelines established by the International Conference on Harmonization and with the Declaration of Helsinki. Written informed consent was obtained from both parents or guardians and subjects aged ≥12 years before enrollment. This study was registered at the EU Clinical Trials database (EudraCT number: 2013–001823-38) and at the Dutch Trial Register (ExternalRef removed; NTR4430).
: Not applicable.
: MBvR, FRMvdK, DMvR, and GAMB report no conflict of interest. EAMS declares to have received research grants from GlaxoSmithKline and from Pfizer.
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