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Article History

Received: 2 July 2018

Accepted: 22 December 2018

First Online: 22 January 2019

Ethics approval and consent to participate

: The ProHEAD consortium received full ethical approval from the Ethics Committee I of the Medical Faculty of the University of Heidelberg (Ethics Committee No.: S-086/2018) on 1 March 2018. Secondary ethics votes for conducting ProHEAD in the respective federal states of the five recruiting centres within the ProHEAD consortium have been applied for. The trial has obtained a trial registration number from the German Clinical Trials Register: DRKS00014606, registered on 20 April 2018. Participants and their legal guardians provide written informed consent before participating in the first school-based assessment and they are free to withdraw consent at any time. The Ethics Committee of the Medical Faculty of the University of Heidelberg will be informed in case of severe adverse events and other unintended effects of trial participation. The study will be conducted in accordance with the ethical principles following the Declaration of Helsinki (DoH), 1996, and the Guidelines for Good Clinical Practice (ICH-GCP) in the latest revision. Data collection, storage and analysis will adhere to National and European Data Protection Laws.

: Not applicable.

: The authors declare that they have no competing interests.

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