Müller, A. R.
den Hollander, B.
van de Ven, P. M.
Roes, K. C. B.
Geertjens, L.
Bruining, H.
van Karnebeek, C. D. M.
Jansen, F. E.
de Wit, M. C. Y.
ten Hoopen, L. W.
Rietman, A. B.
Dierckx, B.
Wijburg, F. A.
Boot, E.
Brands, M. M. G.
van Eeghen, A. M.
Funding for this research was provided by:
GWResearch/Jazz pharmaceuticals
Dutch TSC foundation
Article History
Received: 27 July 2023
Accepted: 29 November 2023
First Online: 4 January 2024
Declarations
:
: This protocol is approved by the institutional review board of the Amsterdam UMC, location AMC (METC 2022_0580). The study will be conducted in accordance with the principles of the Declaration of Helsinki (2013), the EU General Data Protection Regulation, the Dutch Medical Research Involving Human Subjects Act and Good Clinical Practice guidelines, the Dutch Act on Implementation of the General Data Protection Regulation, and the Amsterdam UMC standard operating procedures. The study is registered under EudraCT number 2021-003250-23, protocol no. NL78162.018.21, version 4.0, registration date 25 August 2022.Participants and caregivers will receive a letter with information about the objectives, background and study procedures with a maximum of three months to consider their decision regarding the study’s progress. Given that the study population includes children, and as most of the participants will suffer from ID, the legal representative(s) will be asked to sign the informed consent. Participants will be informed about the study adjusted to their level of intellectual functioning. Participants and legal representatives are allowed to contact the research team when remaining questions are present during the entire trial period.
: Not applicable.
: The authors declare no competing interests.