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Article History

Received: 22 July 2019

Accepted: 5 July 2020

First Online: 24 July 2020

Ethics approval and consent to participate

: The study protocol was approved by the following ethics committees in the participating countries: Ethikkommission der Medizinischen Universität Wien (Austria), Ethikkommission des Landes Kärnten (Austria); Lübeck (Germany); Ethikkommission der Universitätsmedizin Göttingen (Germany); Health Research Authority (UK); Comité consultatif sur le traitement de l’information en matière de recherche dans le domaine de la santé (CCTIRS) (France); Commission Nationale de l’Informatique et des Libertés (CNIL) (France); Conseil National de l’Ordre des médecins (CNOM) (France); UCL Brussels (Belgium); CHU Liège. Domaine Universitaire du Sart Tilman (Belgium); Ethics Committee UZ Leuven (Belgium); Ethics Committee UZ Brussels (Belgium); Commission cantonale d’éthique de la Recherche Gèneve (CCER) (Switzerland); Kantonale Ethikkommission Zürich (Switzerland); CEIC Fundació Puigvert (Spain); CEIC Hospital Clínic de Barcelona (Spain); CEIC Hospital Universitario de Getafe (Spain); CEIC Hospital Universitari Vall d’Hebrón (Spain). All participants provided written informed consent.

: Consent to publish was not required for this manuscript as no patient data are reported.

: DJ: DJ received honoraria from Otsuka (from lectures and for participating in Advisory Boards) and is the principal investigator for studies conducted by Otsuka and Ipsen.JQ: employee of BioMarin Pharmaceutical Inc.JYL: employee of Otsuka Pharmaceutical Europe Ltd.SM: employee of Otsuka Pharmaceutical Europe Ltd.KO: employee of Otsuka Pharmaceutical Europe Ltd.JSC: employee of Otsuka Pharmaceutical Europe Ltd.JWS: employee by Otsuka Pharmaceutical Europe Ltd.HD: employee of Clinical Outcomes Solutions.