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Article History

Received: 13 February 2019

Accepted: 23 April 2019

First Online: 6 May 2019

Ethics approval and consent to participate

: The trial will be conducted in compliance with the principles of the Declaration of Helsinki (current version), the principles of good clinical practice (GCP) and in accordance with all applicable regulatory requirements. The protocol and related documents were submitted for review and approved by the leading Medical Ethics Committee of the University Hospital of the Vrije Universiteit Brussel (UZ Brussel, Brussels, Belgium) on May 16th 2018 (B.U.N. 143201835875). This approval includes the advices of the non-leading Medical Ethics Committees of the participating hospitals, i.e. UZ Leuven (KULeuven), Jessa Ziekenhuis Hasselt and Ziekenhuis Oost-Limburg Genk. In addition, an amendment of the protocol was submitted for review and approved by the same leading Medical Ethics Committee on October 29th 2018. Any other amendments will be communicated with the leading Medical Ethics Committee. The study can and will be conducted only on the basis of prior written informed consent by the subjects to participate in the study. All data will be coded, the subjects’ names or other identifiers will be stored separately from the research data and replaced by unique codes to create new identities for each individual subject. Only researchers involved in the study will have access to the data.

: Not applicable.

: The authors declare that they have no competing interests.

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