Funding for this research was provided by:
Nederlandse Organisatie voor Wetenschappelijk Onderzoek (NWA.1160.18.200)
Received: 3 December 2021
Accepted: 1 June 2022
First Online: 7 July 2022
: This study protocol has been reviewed and approved by the medical ethics committee of Utrecht, The Netherlands (‘Medisch ethische toetsingscommisie (METC) Utrecht’) (reference number NL73520.041.20) and has been registered at the Eudra CT database (EudraCT: 2020–002196-35). A protocol revision chronology and a trial registration data set are provided in appendices II and III respectively. Participants and their parents/guardians will receive verbal and written information about the study. Separate information sheets and consent forms are available for parents/guardians, children below the age of 12, children aged 12 to 16 and adolescents above the age of 16. The coordinating or principal investigator will obtain written informed consent from all participants before inclusion. Parents/guardians provide written informed consent for children below the age of 12. Children and adolescents above the age of 12 provide their own written informed consent, combined with written informed consent by the parent/guardian in case the participant is below the age of 16 years.Monitoring will be conducted by the clinical research bureau (CRB) of the VUmc. The CRB is an independent party that monitors all WMO research at the VUmc. Study monitors will visit the study site at regular intervals to monitor the execution of the study. Monitors will have access to all documents that are needed to perform their task according to the ICH-GCP guidelines. Monitors will check whether requirements to conduct the study are met and study procedures are followed correctly, and will check the study site’s documentation, the participants’ source data, eCRF entries, and the correct maintenance of the Investigator Site File. Investigators will permit trial-related monitoring, audits, ERB reviews and regulatory inspections, providing direct access to source data and study documents.
: Not applicable.
: HB is shareholder of Aspect Neuroprofiles BV, which provides EEG-analysis services for clinical trials. All other authors declare that they have no competing interests.