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The project has received support from the European Medicines Agency under the Framework service contract nr EMA\/2018\/28\/PE. The content of this paper expresses the opinion of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"All authors declared the funding statement mentioned above. Otherwise, SA, RP, JRA, MG, EA, VH, CB, SBK, PGP, HG, RG, AG, CH, LI, GL, MMP, OP, GR, PS, KW and OK declared none. CED is a board member of the International Society for Drug Bulletins, with no payments involved. MA declares grants or contracts from Novo Nordisk Foundation (NNF15SA0018404) to his institution, and fees from Atrium, the Danish Pharmaceutical Industry Association for leading and teaching pharmacoepidemiology courses. JB declares unrelated consultancy fees from CorEvitas LLC and WHO Regional Office for Europe, and scholarship to attend ICPE 2022 from International Society for Pharmacoepidemiology. CEH declares grants or contracts from Novo Nordisk A\/S, H. Lundbeck A\/S, Ferring Pharmaceuticals and Leo Pharma, also funding of PhD projects to Department of Pharmacy, University of Copenhagen. EH and KMAS are employees of the PHARMO Institute for Drug Outcomes Research. This independent research institute performs financially supported studies for government and related healthcare authorities and several pharmaceutical companies. MS declares grants or contracts from Pfizer, AstraZeneca and Janssen to her institution, not related to this work.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"In Denmark, the Danish National Prescription Registry was accessed through the Research Service Unit of Statistics Denmark (FSEID-00004357\/DST-project no. 707524), and approval for processing of personal health data was obtained through the UCPH (ref. no.: 514-0301\/19-3000). In Italy, the participation to the EMA Lot4 study on valproates was included in ARS Toscana workplan and it did not require any further ethical approval. In the Netherlands, the EMA Lot4 study on valproates has been approved for compliance with the general data protection regulation by the Institutional Review Board of \u2018Stichting Informatie voorziening voor Zorg en Onderzoek\u2019 (dd. 10 Oct 2019). In Spain, the favourable approval was received from BIFAP scientific committee (reference num. 19_2019) on 23.02.2020, and from the Comit\u00e9 de \u00c9tica de la Investigaci\u00f3n Con Medicamentos Regional de la Comunidad de Madrid-CEIm-R (Acta 02\/20) on 10.02.2020. In the UK, the study proposal was reviewed and approved by the Independent Scientific Advisory Committee of the Clinical Practice Research Datalink (reference 20_009), which is responsible for reviewing protocols for scientific quality.","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":"This multicentre study used anonymised patient data from electronic health care databases in different countries\/regions. These data remained local within each centre and will not be distributed publicly. No additional data available.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and materials"}},{"value":"All analyses scripts are open source and are publicly available at:\n                      \n                      .","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"All authors contributed to intellectual concept and design of the research. SA, RP, CED, MG and EA wrote and checked the common analysis scripts for distributed analyses and conducted the final aggregated analyses. MA, SBK and CEH conducted the data acquisition and data analysis for Danish National Registries, Denmark. RG, AG, CB, GL, OP and GR performed the data acquisition and data analysis for ARS Tuscany, Italy. EH and KS carried out the data acquisition and data analysis for PHARMO, the Netherlands. PGP, CH, MMP carried out the data acquisition and data analysis for BIFAP, Spain. JB and KW conducted the data acquisition and data analysis for CPRD, UK. All authors contributed to data interpretation. SA, RP, CED, JRA and VH were in charge of quality control processes. SA and RP wrote the manuscript. All authors were involved in editing the manuscript. All authors are accountable for their own contribution, in addition to all aspects of the manuscript. All authors have approved the (re)submitted version of the manuscript.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}