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Reynolds has received project grants and personal fees from Genzyme Therapeutics (now Sanofi Genzyme), Shire Pharmaceuticals (now Takeda), and Synageva BioParma (now Alexion Pharma UK); payment for lectures from Sanofi, Shire (now Takeda), and AstraZeneca. P. Carey has received honorarium and personal fees from Sanofi. J. George has no conflicts of interest to declare. G. Konidaris is an employee of Sanofi. D. Narayanan has received honoraria from Sanofi. S. Ramachandran has received honoraria from Sanofi, Novo Nordisk, Napp, Janssen, AstraZeneca, Besins Healthcare; educational grants from Sanofi and Besins Healthcare; and a research grant from Bayer PLC. L Saunders is an employee of OPEN VIE (formerly pH Associates), which has been funded by Sanofi for the statistical and analytical execution of this study. L. Saunders has no other conflicts of interest to declare. A. Viljoen has received funding and\/or conducted research studies funded by AstraZeneca, Boehringer Ingelheim, Amgen, Novo Nordisk, Napp, Janssen, Eli Lily, and Sanofi Aventis. G. Ferns has received grants, non-financial support, and other fees from Sanofi; and other fees from Amgen.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Anonymized patient-level data, corresponding to a predefined core data set, were collected from electronic medical notes and paper charts and entered into a database. The database used was compliant with the Code of Federal Regulations 21 (Part 11) and approved for use in the National Health Service (NHS) setting. The study was conducted in accordance with the principles of the 18th World Medical Assembly (Helsinki, 1964) and all its subsequent amendments (up to 2013) and with the International Society for Pharmacoepidemiology guidelines for Good Pharmacoepidemiology Practice 19, in accordance with local regulations, including local data protection regulations.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Research involving human participants"}}]}}