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Authors
Thoen, Anoushka http://orcid.org/0000-0001-6408-220X
Steyaert, Jean http://orcid.org/0000-0003-2512-4694
Alaerts, Kaat http://orcid.org/0000-0001-8665-6374
Van Damme, Tine http://orcid.org/0000-0002-8197-6704
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Funding
Funding for this research was provided by:
Marguerite-Marie Delacroix Foundation (GV/B-363)
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Article History
Received: 29 April 2021
Accepted: 8 October 2021
First Online: 21 October 2021
Declarations
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: Ethical approval for this study was granted by both the Ethics Committee UPC KU Leuven on July 2, 2020 (ref. EC2020-541, version 1.0) and the Ethics Committee Research UZ/KU Leuven on October 20, 2020 (ref: S64219, version 2.0) and on April 9, 2021 (ref: S64219, version 3.0, amendment). A copy of the original approval and its translation has been added as “Additional File InternalRef removed, 1b, 1c and 1d.” The researchers will permit study-related monitoring, audits, Ethical Committee review and regulatory inspection, providing direct access to all related source data/documents. Every substantial adjustment to the protocol will be communicated to the Ethics Committee UPC KU Leuven and the Ethics Committee Research UZ/KU Leuven as an amendment to the protocol. Only after approval of this amendment, the adjustments can be implemented and communicated to the researchers and participants.Parents of the participants should provide informed consent in addition to the informed assent provided by the participants themselves. The informed consent and assent forms will be gathered by AT. Participants may withdraw consent and participation at any time. The participant’s request to withdraw from the study will always be respected and reasons to withdraw are not obliged to be mentioned. The sponsor of this study is KU Leuven (Oude Markt 13, 3000 Leuven, Belgium) and will have no role in any part of this study. Translated versions have been added as “Additional File InternalRef removed and 4b.”
: Authorship to publications will be determined in accordance with the requirements published by the International Committee of Medical Journal Editors and in accordance with the requirements of the respective peer-reviewed medical journal. There will also be a general dissemination of the study results for the participants and personal results will be provided upon request.
: The authors declare that they have no competing interests.
