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Article History

First Online: 8 May 2019

Compliance with Ethical Standards

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: BPE research group at the University of Bordeaux is managed by ADERA, a non-profit organisation, which manages research grants from various companies, none of which is directly relevant to the content of this study. Estelle Guiard, Magali Rouyer, Emmanuelle Bignon, Regis Lassalle, Cécile Droz-Perroteau and Patrick Blin are employees of ADERA, and declare no conflicts of interest other than that relevant to the funding of the study. Benedicte Lelièvre is an employee of Angers University Hospitals and declares no conflicts of interest other than that relevant to the funding of the study. Frank Zerbib is an employee of Bordeaux University, and declares having received research funding from Takeda and Sandhill Scientific, consultancy fees from Allergan and has participated as a speaker at events funded by Allergan, Biocodex, Vifor Pharmaceuticals, Mayoly Spindler and Ipsen. Bertrand Diquet is an employee of University of Angers and declares no conflicts of interest other than that relevant to the funding of the study. Francis Mégraud is an employee of Bordeaux University, and reports research grants from Allergan and Biomerieux, Consulting fees from Mayoly Spindler and support for travel to meetings from Pfizer. François Tison is an employee of University of Bordeaux, and declares no conflicts of interest. Nicholas Moore is an employee of University of Bordeaux and reports consulting fees for training and safety advice from Sanofi, Pfizer, Merck, Novartis, and other pharmaceutical companies, none of which was in the scope of the study. There are no conflicts of interest that are directly relevant to this study.

: AXCAN (now ALLERGAN) funded this study as part of a post-marketing commitment to the French national regulatory authorities, which reviewed the protocol and received the final study report. The funding received was entirely managed by University of Bordeaux and ADERA, the non-profit organisation that provides financial and HR management to our research team.

: This study was mandated by the French Health Authority (ANSM) as a post-marketing commitment at the time of approval of the medication in France. The study protocol received all legal authorisations from the National Advisory Committee on Medical Research Information (CCTIRS) and the French national data protection agency (CNIL). The protocol was submitted to the Committee for the protections of persons participating in biomedical research (CPP) Sud-Ouest-Outremer III, and approval was obtained on 31 October 2012. All patients provided written informed consent. The study was conducted according to ENCePP guidance on methodological standards in pharmacoepidemiology and obtained an ENCePP study seal (EU-PAS register EUPAS3142).