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Article History

Received: 2 July 2018

Accepted: 22 December 2018

First Online: 15 January 2019

Ethics approval and consent to participate

: The ProHEAD consortium including the E.motion trial was reviewed and approved by the ethics committee of the Medical Faculty, University of Leipzig, on 30 May 2018, reference number 181/18-lk, and by all responsible ethics committees of the participating study sites (University of Heidelberg, reference number S-086/2018).The trial will follow the Declaration of Helsinki (DoH), 1996, and the Guidelines for Good Clinical Practice (ICH-GCP) in the latest revision. Written informed consent will be obtained from all participating C&A and their legal guardians to participate in the study. Copies of the consent forms will be kept in the trial site files. Internet-based platforms to assess data and to deliver the interventions will follow latest regulations concerning data security. All collected information will be confidential and held in accordance with ICH-GCP. Participants will be free to withdraw consent from the study at any time without giving a reason.

: Not applicable.

: The authors declare that they have no competing interests.

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