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Michael Schultze and Marc Pignot are employees of ZEG \u2013 Berlin Center for Epidemiology and Health Research GmbH, which was contracted by GSK to conduct this study. Mary Elizabeth Georgiou and Jacob N Hunnicutt are employees of GSK and hold stocks and shares in the company. Kerry Gairy was an employee of GSK at the time this study was conducted and holds stocks and shares in the company (current affiliation: AstraZeneca, Global Market Access and Pricing, Cambridge, UK).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"This article does not contain any studies with human participants or animals performed by any of the authors. Permission was granted for this specific use of the Betriebskrankenkassen German Sickness Fund database. All methods with respect to data acquisition\/extraction\/preparation\/verification were performed in accordance with relevant guidelines and regulations. 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