van Andel, Dorinde M.
Sprengers, Jan J.
Oranje, Bob
Scheepers, Floortje E.
Jansen, Floor E.
Bruining, Hilgo
Funding for this research was provided by:
Stichting TSC Fonds
Article History
Received: 23 August 2019
Accepted: 7 April 2020
First Online: 7 May 2020
Ethics approval and consent to participate
: The medical ethical committee (METC) of the UMC Utrecht approved the trial protocol and the study is conducted according to the principles of the Declaration of Helsinki, version of Fortaleza, 2013, the International Conference on Harmonisation–Good Clinical Practice (ICH-GCP) and in accordance with the Medical Research Involving Human Subjects Act (WMO). Written informed consent was obtained from all parents and participants.
: Not applicable.
: The authors declare that they have no competing interests.