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For this study, informed consent to participate was not applicable. No surveys or examinations were carried out on patients. The analysed data are routinely collected and stored in the adverse drug reaction database EudraVigilance from the European Medicines Agency (EMA). Among others, pharmaceutical companies, physicians, pharmacists and patients report these ADRs (information concerning the reporting channels see Dubrall et al. 2018 [25]). 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                      - human-ev_en.pdf). The Federal Institute for Drugs and Medical Devices (BfArM) as a national competent authority is granted with the highest level of access to EudraVigilance since one of the core duties of the BfArM is to analyse EudraVigilance data to fulfil its pharmacovigilance obligations.","order":2,"name":"Ethics","label":"Ethics approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":3,"name":"Ethics","label":"Consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":4,"name":"Ethics","label":"Consent for publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The pseudonymised ADR reports from EudraVigilance are not publicly available and cannot be provided upon request due to data protection requirements. To fulfil their legal obligations distinct levels of access to EudraVigilance are provided for various stakeholders (\n                      \n                      ). The Federal Institute for Drugs and Medical Devices, being one of the competent authorities in Germany, is granted with the highest level of access covering the individual spontaneous adverse drug reaction (ADR) reports. This access to the individual spontaneous ADR reports from EudraVigilance is not granted to the public and cannot be provided upon request due to data protection requirements. However, a lower level of access is granted to the public thereby enabling researchers to perform the same analysis in EudraVigilance albeit with aggregated data (public access:\n                      \n                      ). For further information regarding the processing of personal data in the context of the operation of EudraVigilance Human, we refer to the European Medicines Agency\u2019s Data Protection Notice for EudraVigilance Human.","order":5,"name":"Ethics","label":"Availability of data and materials","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"A description of the code can be found in Online Resource 1. The R code files can be found in\u00a0Online Resource 2-5. Please store the code included in Online Resource 2-5 as R files with the following names \"Source1_csv.R\", \"Source2_csv.R\", \"Source3_csv.R\", and \"UserFile_EudraScore.R\" in the same folder as the data set to be analysed. Subsequently, open \"UserFile_EudraScore.R\" and follow the instructions.\u00a0","order":6,"name":"Ethics","label":"Code availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"DD and MS are supported by the EVAS project, which is founded by the Federal Institute for Drugs and Medical Devices and the Institute for Medical Biometry, Informatics and Epidemiology of the University Hospital Bonn.","order":7,"name":"Ethics","label":"Conflicts of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Study design (DD, PC, BS, DL, TG, RH, MS), formal analysis (DD, PC), interpretation of data (DD, PC, BS, MS), writing\u2014original draft (DD), writing\u2014review and editing (PC, BS, MS, DL, TG, RH). All authors read and approved the final version of the manuscript. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.","order":8,"name":"Ethics","label":"Authors\u2019 contribution","group":{"name":"EthicsHeading","label":"Declarations"}}]}}