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KiDSafe was funded by the German innovation fund of the Federal Joint Committee (G-BA) under the fund mark 01NVF16021. Antje Neubert received funding from the German Ministry of Health and German innovation fund of the Federal Joint Committee (G-BA).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Sarah Leitzen, Diana Dubrall, Irmgard Toni, Julia Stingl, Patrick Christ, Ursula K\u00f6berle, Matthias Schmid, Antje Neubert, and Bernhardt Sachs have no conflicts of interest to declare.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Approval for the protocol of the KiDSafe project was obtained from the Ethics Committee of the Friedrich-Alexander University Erlangen-N\u00fcrnberg under reference number 351_17 B, and approval for the analysis of the spontaneous reports from EudraVigilance was obtained from the local Ethics Committee of the Medical Faculty of Bonn (009\/17 and 100\/21).","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics 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 to publication"}},{"value":"Due to data protection requirements and the EudraVigilance access policy, the individual pseudonymized case reports are not accessible to the readership since different levels of access are granted for different stakeholders []. The Federal Institute for Drugs and Medical Devices (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 EudraVigilance with aggregated data (public access:).","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"Sarah Leitzen, Diana Dubrall and Bernhardt Sachs contributed to the conception and design of the analysis. Irmgard Toni and Antje Neubert contributed to the design of the analysis of the KiDSafe data and provided input to the interpretation and discussion of the data. Patrick Christ and Diana Dubrall contributed to data evaluation. Ursula K\u00f6berle gave advice regarding ADR reporting and supervised the recording and assessing within the DCGMA. The first drafts of this manuscript were written by Sarah Leitzen and Bernhardt Sachs. All authors commented on previous versions of the manuscript, and read and approved the final version.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors' contributions"}}]}}