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Antje Neubert was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Severin Domg\u00f6rgen and Armin Str\u00f6bel received funding from the MEKIH project [\n                      \n                      ]. MEKIH is funded by the German Innovation Fund of the Federal Joint Committee (G-BA) under the fund mark 01VSF22045. Claudia Kayser, Irmgard Toni, Bernhardt Sachs, and Diana Dubrall have no conflicts of interest that are directly relevant to the content of this article.","order":1,"name":"Ethics","label":"Conflict of Interest\/Competing Interests","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The Ethics Committee of the North Rhine Medical Association waived the need for approval as this is not required for retrospective analyses based of pseudonymised spontaneous reports from EudraVigilance and BfArM's case collection. No surveys or examinations were carried out on patients. The analysed data are routinely collected and stored in EudraVigilance and BfArM's case collection. Further information concerning the processing of personal data in the context of the operation of EudraVigilance Human can be found in the European Medicines Agency\u2019s Data Protection Notice for EudraVigilance Human (\n                      \n                      ).","order":2,"name":"Ethics","label":"Ethical Approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Given the nature of the data, consent to participate is not applicable.","order":3,"name":"Ethics","label":"Consent to Participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Given the nature of the data, consent for publication is not applicable.","order":4,"name":"Ethics","label":"Consent for Publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Because of data protection requirements and the EV access policy, the individual pseudonymised case reports are not accessible to the readership as different levels of access are granted for different stakeholders (\n                      \n                      ). BfArM, as the competent authority in Germany, is granted the highest access level. However, even with the lowest level of access, researchers can perform the same analyses in EV with aggregated data (public access:\n                      \n                      ). Medication error case collection of the BfArM is a BfArM internal database. Data cannot be shared because of data protection requirements. Only staff of the institute can perform analysis within this database.","order":5,"name":"Ethics","label":"Availability of Data and Material","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"No new software was developed as part of the project.","order":6,"name":"Ethics","label":"Code Availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All authors contributed to the conception and design of the analysis. SD and DD contributed to data evaluation of the EV case collection. The first drafts of the manuscript were written by SD, DD and BS. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.","order":7,"name":"Ethics","label":"Authors\u2019 Contributions","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The information and views set out in this article are those of the authors and do not necessarily reflect the official opinion of the Federal Institute for Drugs and Medical Devices (BfArM).","order":8,"name":"Ethics","label":"Disclaimer","group":{"name":"EthicsHeading","label":"Declarations"}}]}}