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Authors
Guntinas-Lichius, Orlando http://orcid.org/0000-0001-9671-0784
Geißler, Katharina
Asendorf, Thomas
Tostmann, Ralf
Löhler, Jan
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Funding
Funding for this research was provided by:
Federal Joint Committee
Friedrich-Schiller-Universität Jena
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Article History
Received: 13 November 2020
Accepted: 7 July 2021
First Online: 22 July 2021
Declarations
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: The conduct of this study will be in accordance with the recommendations for physicians involved in research on human subjects adopted by the 18th World Medical Assembly, Helsinki 1964, and later revisions. This clinical trial protocol has been approved by central ethics committee of the trial, the ethics committee of the University of Jena, Germany (No. 2020-1839-BO). Prior to randomization, written informed consent will be obtained from the patients, or parents/caretakers of each underage participant.
: The consent forms (four versions dependent on the age of the patient: 3–6 years, 7–11 years, 12–15 year, 16+ years, and for caregivers) and other related documentation will be given to participants and presented to authorized surrogates (Additional files InternalRef removed, InternalRef removed, InternalRef removed, InternalRef removed and InternalRef removed).
: The authors declare that they have no competing interests.
