Funding for this research was provided by:
Received: 18 November 2019
Accepted: 26 January 2020
First Online: 11 February 2020
Change Date: 29 July 2020
Change Type: Correction
Change Details: An amendment to this paper has been published and can be accessed via the original article.
Ethics approval and consent to participate
: All patients provided their informed consent to participate in the study. This study is non-interventional, and therefore falls outside the scope of the European Union (EU) Directive 2001/20/EC and the EU Directive 2005/28/EC. As required by applicable local regulations, the Sponsor’s Regulatory Affairs group ensured all legal regulatory aspects were covered, and obtained approval from the appropriate regulatory bodies, prior to study initiation, in regions where an approval was required. This study adhered to all local regulatory requirements applicable to non-interventional studies. Before initiating the study, the Investigator/institution had written and dated approval/favourable opinion from the Independent Ethics Committee (IEC)/Institutional Review Board (IRB) as applicable in the country. The study was conducted in accordance with the protocol, Guidelines for Good Clinical Practice, and the ethical principles laid down in the Declaration of Helsinki.
: Not applicable
: JL, ND and PM are employees of Ipsen. MH is a paid employee of ICON plc, and Ipsen provided funding to ICON plc in connection with this study. VPM reports consultancy for Ipsen.