Funding for this research was provided by:
Bundesministerium für Bildung und Forschung (01GL1745E)
Article History
Received: 5 November 2020
Accepted: 11 November 2020
First Online: 25 November 2020
Ethics approval and consent to participate
: The current study complies with the standards of Good Clinical Practice (GCP) and was approved by the Ethics Committee of the Medical Faculty of the University of Rostock (registration number: A 2018–0002, amendment after feasibility period of 26.05.2020). According to the ethics commission, there are no objections from a professional and ethical point of view to the implementation and continuation of the research project. Furthermore a Data and Safety Monitoring Board has been established in which persons independent of the study stuff and sponsor ensure the safety of the participants and the data collected. All participants receive detailed written information about the study project and give informed consent to the research team. Informed parental (or from legal guardian) consent will be received for all participants under the age of 16. Extensive study information (flyer) will be handed out and opportunities to ask questions will be provided. If unexpectedly serious adverse events occur, they will be documented and reported to the Data and Safety Monitoring Board. This board is an independent consultative committee that can make recommendations to the study organisers. Together with the research team, a decision will be made on how to proceed (e.g. discontinuing training, exclusion of participants from the study, counselling or medical support). Furthermore, the study is supervised by the external monitoring company responsible for essential organizational and administrative services for the preparation, execution and follow-up of this clinical study.
: Not applicable.
: The authors declare that they have no competing interests.