107 SCOPE study design 5 Declarations Ethics approval and consent to participate The study is conducted according to the principles of the Declaration of Helsinki (version 64th, October 2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO) and other guidelines, regulations and acts. The study is approved by the medical ethics Committee on Research involving Human Subjects (CCMO, Arnhem-Nijmegen) and is registered under number 2018-4309. Consent for publication Written informed consent regarding participation and publication from all parents or guardians for participants under 16 years will be obtained during the randomized controlled trial. Competing interests. Jan K Buitelaar has been in the past 3 years a consultant to / member of advisory board of / and/or speaker for Takeda/Shire, Roche, Medice, Angelini, Janssen, and Servier. He is not an employee of any of these companies, and not a stock shareholder of any of these companies. He has no other financial or material support, including expert testimony, patents, royalties. Funding. This work was supported by the Korczak Foundation (Grant No. 2018-01) and was further supported by (1) the EU-AIMS (European Autism Interventions) and AIMS2-TRIALS programmes which receive support from Innovative Medicines Initiative Joint Undertaking Grant No. 115300 and 777394, the resources of which are composed of financial contributions from the European Union’s FP7 and Horizon2020 Programmes, and from the European Federation of Pharmaceutical Industries and Associations (EFPIA) companies’ inkind contributions, and AUTISM SPEAKS, Autistica and SFARI, and (2) the EU Horizon2020 programme CANDY (Grant No. 847818). The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results. Any views expressed are those of the author(s) and not necessarily those of the funders. Availability of data and materials’ The final dataset of the randomized controlled trial will be available (anonymized) for other researchers at the end of the study.
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