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Chapter 494be filled out weekly by primary caregivers, which can be completed within a few minutes. The other outcome measures will be scored once during the baseline period, at the end of each interventional (including placebo) period, with a total of five measurements, and if participating in the optional extension phase at the follow-up measurement. Adverse effects will be assessed as well. The questionnaires can be filled out digitally (Castor EDC), phone or on paper forms. Caregivers will be asked to report all seizures in the seizure diary. To reduce burden, assessments occur by phone calls except for the clinical visits. During the experiment, it will be attempted to not switch rating caregivers. Optional open-label extension phaseIn consultation with the primary caregivers, patients may continue with CBD treatment during an optional one-year open-label extension phase after which a final contact moment takes place. At this follow-up measurement, questionnaires will be filled out again and personalized goals will be evaluated. Safety evaluationAdverse eventsAdverse events (AEs) will be monitored throughout the N-of-1 trials. All SAEs and Suspected Unexpected Serious Adverse Reactions (SUSARs) occurring during the study and either reported spontaneously or as part of the AE monitoring will be followed up by the principal investigator and will be reported separately to the Medical Ethics Committee (MEC). Unblinding will occur if there is reason to believe a SAE or SUSAR was due to the study medication and if the patient cannot be treated without knowing which treatment they were receiving. Unblinding and the reason for unblinding will be recorded. AEs, SAEs and SUSARs will be followed until they have abated or a stable situation has been reached. Removal from the trial and replacement of participantsParticipants will be removed from the study if informed consent is withdrawn. The investigator can decide to withdraw a participant from the N-of-1 trial for urgent medical reasons. Participants with hepatic enzyme level elevations sex times or greater the levels measured during baseline will be excluded, as this is a known potential for drug-induced liver injury with CBD. Annelieke Muller sHL.indd 94 14-11-2023 09:07