Vanaudenhove, Thibault
Van Muylem, Alain
Howarth, Nigel
Gevenois, Pierre Alain
Tack, Denis
Article History
Received: 16 February 2020
Revised: 4 March 2020
Accepted: 17 March 2020
First Online: 8 April 2020
Compliance with ethical standards
:
: The scientific guarantor of this publication is Denis Tack.
: The authors of this manuscript declare no relationships with any companies whose products or services may be related to the subject matter of the article.
: One of the authors has significant statistical expertise.
: Written informed consent was not required for this study since, according to EU legislation (i.e., the Regulation (EU) 2016/679 regarding the protection of data of individuals), a purely observational study with complete anonymization of the data at the source, which removes any possibility of identifying the individual patients, is not subject to ethical review. See “The European parliament and the council of the European Union (2016) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC. OJ L 119, 4.5.2016, p. 1–88. Available via ExternalRef removed Accessed 24 Oct 2019.”
: Institutional Review Board approval was not required because see above.
: • Retrospective• Observational• Multicenter study