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First Online: 4 March 2019

Compliance with Ethical Standards

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: This study was funded by Servier under a contract granting independent publication rights to the research team. Servier co-authors of this manuscript, Emmanuelle Jacquot and Nicolas Deltour, provided feedback and contributed to the design of the study. The sponsor had the opportunity to review the report and contribute to the dissemination of the results. The open access fee was paid by RTI-HS with general funds from the study account, which was funded by Servier.

: Manel Pladevall, Joan Forns, Miguel Cainzos-Achirica, Jaume Aguado, Jordi Castellsagué, and Susana Perez-Gutthann are employees of RTI Health Solutions, a unit of RTI International, a nonprofit organisation that conducts work for government, public, and private organisations, including pharmaceutical companies like Servier. Alexandra Prados-Torres and Beatriz Poblador-Plou are members of the EpiChron Research Group on Chronic Diseases of the Aragon Health Sciences Institute (IACS), ascribed to IIS Aragón, and do not have any conflict of interest with this project. Maria Giner-Soriano, Rosa Morros, and Jordi Cortés worked on other projects funded by pharmaceutical companies in their institution that were not related to this study and without personal profit. Tania Schink and Tammo Reinders, as employees of the Leibniz Institute for Prevention Research and Epidemiology – BIPS, worked on projects funded by pharmaceutical companies unrelated to this study and without personal profit. Anton Pottegård reports participation in research projects funded by Alcon, Almirall, Astellas, Astra-Zeneca, Novo Nordisk, LEO Pharma, and Servier, all with funds paid to the institution where he was employed (no personal fees) and with no relation to the work reported in this paper. Jesper Hallas has participated in research projects funded by Novartis, Pfizer, Menarini, MSD, Nycomed, LEO Pharma, Almirall, Servier, Astellas, and Alkabello, with grants paid to the institution where he was employed. He has personally received fees for teaching or consulting from the Danish Association of Pharmaceutical Manufacturers and from Pfizer and Menarini. Maja Hellfritzsch has received speaker honorarium fees from Bristol-Myers Squibb and Pfizer and a travel grant from LEO Pharma. Johan Reutfors, David Hägg, and Lena Brandt are employees of the Centre for Pharmacoepidemiology, which receives grants from several entities (pharmaceutical companies, regulatory authorities, and contract research organisations) for the performance of drug safety and drug utilisation studies. Gabriel Perlemuter reports participation in research projects funded by Biocodex, Servier, Physiogenex, Gilead, and Pileje as an external expert consultant. He received royalties from Elsevier-Masson, Solar, and John-Libbey and reports travel and participation in meetings funded by Gilead, Abbvie, and Servier. Bruno Falissard has been consultant for E. Lilly, BMS, Servier, Sanofi, GSK, HRA, Roche, Boeringer Ingelheim, Bayer, Almirall, Allergan, Stallergene, Genzyme, Pierre Fabre, AstraZeneca, Novartis, Janssen, Astellas, Biotronik, Daiichi-Sankyo, Gilead, MSD, Lundbeck, Stallergene, Actelion, UCB, Otsuka, Grunenthal, and ViiV. Prof. Antje Timmer participates in a project funded by a consortium of pharmaceutical companies not related to this study and without personal benefit. Nicolas Deltour and Emmanuelle Jacquot are employees of Servier. The statistical analysis was performed by the different research partners in each data source. In EpiChron, the main contributor to the analysis was BP; in SIDIAP, it was JC; in Denmark, it was AP; in GePaRD, the main contributors were TS and TR; and in Sweden, the main contributors were DH and LB. The study protocol is publicly available at the European Union Electronic Register of Post-Authorisation Studies [EU PAS Register # EUPAS10446] [].

: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. For this type of study, formal consent is not required.