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Morales, Adrien Inoubli, Jean-Michel Dogn\u00e9, and Sabine M.J.M. Straus have no conflicts of interests that are directly relevant to the content of this article. The views expressed in this article are the authors\u2019 personal views and may not be understood or quoted as being made on behalf of or reflect the position of the EMA or one of its committees or working parties.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Not applicable.","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 for publication"}},{"value":"The study used the records described and referenced with an access option as applicable in Sect.\u00a0InternalRef removed. The data analyses are provided in Appendix 3 of the ESM.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"The study was designed by P.B. in consultation with the PRAC Impact Strategy Group (IG), which included D.M. and S.M.J.M.S., and in collaboration with J.-M.D. The ASSET was developed by P.B. following consultation of the approach with the IG, and D.M. reviewed the plausibility of the draft tool. Content analysis was performed by P.B. and its results reviewed for appropriate interpretation of the data by S.M.J.M.S. and J.-M.D., as the PRAC rapporteur and co-rapporteur for the 2017\u201318 EU procedure on valproate respectively. P.B. drafted the study report, which was critically reviewed by D.M., S.M.J.M.S. and A.I. as a new IG member, resulting in clarifications and revisions. The proposals for PRAC derived from the study results were discussed and finalised by all authors. All authors reviewed and approved the manuscript before submission to the journal as well as the version finalised for publication and agree to be accountable for all aspects of the work, in particular, its accuracy and integrity.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author\u2019s contributions"}}]}}