Funding for this research was provided by:
Stichting tot Steun Vereniging tot Christelijke Verzorging van Geestes- en Zenuwzieken (270)
Received: 1 July 2022
Accepted: 5 October 2022
First Online: 14 October 2022
: The study protocol has been reviewed and approved by the Medical research Ethics Committees United (MEC-U; registration number R20.098). Participants will provide informed consent prior to enrollment in the study. Additionally, for participants under the age of 16, written informed consent will be obtained from their parents as well. The informed consent forms have been approved by the Medical Ethics Committee. The study is registered at the Netherlands Trial Register (NL9564). Approval for amendments to the protocol will be sought by the Ethics Committee, and will be updated in the Netherlands Trial Register. All adverse events will be documented. Any serious adverse events will be reported to the MEC-U. 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.