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Article History

Received: 2 July 2018

Accepted: 22 December 2018

First Online: 30 January 2019

Ethics approval and consent to participate

: The ProHEAD Consortium including the present trial was reviewed and approved by the ethics committee of the University Hospital Heidelberg, on April, 19 (reference number: S-086/2018). Subsequently, ethical approval is sought at all other study sites recruiting participants (Hamburg, Leipzig, Marburg, Schwäbisch Gmünd).The trial will follow the Declaration of Helsinki and the Guidelines for Good Clinical Practice (ICH-GCP) in their latest revision. Written informed consent and assent will be obtained from all participating C&A and from at least one of their primary caregivers. The 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 stating reasons.

: Not applicable.

: The authors declare that they have no competing interests.

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