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Unrelated to this study, BIPS occasionally conducts post-authorisation safety studies (PASSs) requested by health authorities and financed by the pharmaceutical industry. These PASSs are performed in line with the ENCePP Code of Conduct, which means that the design and conduct as well as the interpretation and publication are not influenced by the pharmaceutical industry. The study presented was not funded by the pharmaceutical industry. MF is working at the Federal Institute for Drugs and Medical Devices (BfArM). BfArM is an independent higher federal authority within the portfolio of the Federal Ministry of Health in Germany. MF declares no conflict of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"TS: conceptualisation, methodology, validation, writing\u2014original draft, visualisation. BK: methodology, software, validation, formal analysis, writing\u2014review and editing. MF: writing\u2014review and editing. UH: conceptualisation, methodology, validation, writing\u2014original draft. All authors read and approved the final version.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 contributions"}},{"value":"In Germany, the utilisation of health insurance data for scientific research is regulated by the Code of Social Law. All involved health insurance providers as well as the German Federal Office for Social Security and the Senator for Health, Women and Consumer Protection in Bremen as their responsible authorities approved the use of GePaRD data for this study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics statement"}},{"value":"Informed consent for studies based on claims data is required by law unless obtaining consent appears unacceptable and would bias results, which was the case in this study. According to the Ethics Committee of the University of Bremen studies based on GePaRD are exempt from institutional review board review.","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 BIPS employees 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":"Data availability"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}}]}}