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Chapter 496Premature termination of the studyThe study will be terminated prematurely if more than one participant indicates a great burden of switching between placebo and CBD periods accompanied by serious safety concerns. Data safety monitoring board (DSMB) and monitoringIndependent qualified monitors from the Clinical Monitoring Center (CMC) will monitor the study. Because of the small sample size and the close monitoring of patients, it was not necessary to set up a DSMB.Ethics approval and consent to participateThis protocol is approved by the institutional review board of the Amsterdam UMC, location AMC (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. AnalysisData collection and managementAll data will be collected and handled in accordance with applicable privacy and data protection regulations. We will collect the data according to the FAIR principles (Findable, Accessible, Interoperable, Reusable).79 TrialAnnelieke Muller sHL.indd 96 14-11-2023 09:07