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Article History

Received: 10 November 2017

Accepted: 23 October 2018

First Online: 16 November 2018

Ethics approval and consent to participate

: Ethics approval and data protection approval of the ZOHé study were authorised by the Comité Consultatif sur le Traitement d’Information en matière de Recherche dans le domaine de la Santé (CCTIRS, the French national advisory committee on information processing of research materials in health studies) and the Commission Nationale de l’lnformatique et des Libertés (CNIL, the French independent national data protection authority), as required by French law for observational research regulation. Informed patient consent was obtained verbally prior to study participation as this was an observational study using a conventional treatment. An information note was shared with all eligible patients to inform consent.

: Not applicable.

: All authors received funding from Sandoz for the conduct of the study in their institutions. Additionally, RD has acted on advisory boards for Sanofi, and received research funding from Cephalon, Hospira, Sandoz, Roche, and Teva. JCE has been a board member for Astellas, Janssen, Novartis and Sanofi, and has received research funding from Novartis, Sandoz and Teva. HR, AP, ML and AT have no further conflicts of interest to declare. RFS and IG are employed by Sandoz.

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