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This post-authorization safety study (PASS) was requested by the EMA, financed by Bayer AG and performed in line with the ENCePP Code of Conduct.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Approval of individual study protocols has been granted by the appropriate research ethics committees and regulatory authorities. All studies are registered on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) electronic register and\/or the ClinicalTrials.gov website. All of the studies were conducted in collaboration with ENCePP centres and in accordance with Good Pharmacoepidemiology Practices [].","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics and approval"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"As we are not the owners of the data we are not legally entitled to grant access to the data of the German Pharmacoepidemiological Research Database. In accordance with German data protection regulations, access to the data is granted only to employees of the Leibniz Institute for Prevention Research and Epidemiology\u2014BIPS on the BIPS premises and in the context of approved research projects. Third parties may only access the data in cooperation with BIPS and after signing an agreement for guest researchers at BIPS.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"All authors contributed to the study conception and design or the data acquisition. The first draft of the manuscript was written by AV and UH. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}