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AvE is a medical advisor for Jazz Pharmaceuticals, Inc., and received TSC-related research support from Jazz Pharmaceuticals, Inc., TSC Alliance, the Dutch TSC Foundation, \u2019s Heeren Loo Care Group, and the Dutch Epilepsy Foundation. They are a member of European Reference Network ITHACA. JS is an employee of Jazz Pharmaceuticals, Inc., and holds stock and\/or stock options in the company. PT has received an honorarium from Jazz Pharmaceuticals for participating in the PAG steering committee for the EpiCom trial. SM is an employee of the TSC Alliance. CF and MR have no relevant conflicts to disclose. SA has received funding from Jazz Pharmaceuticals, Inc., Novartis, PTC Therapeutics, Boston Scientific, Nutricia, UCB, BioMarin, LivaNova, Medtronic, Desitin, Ipsen, CDKL5 UK, TSA, and the National Institute for Health Research.","order":1,"name":"Ethics","label":"Conflicts of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All relevant data are provided with the manuscript and supporting files. Jazz Pharmaceuticals\u00a0has established a process to review requests from qualified external researchers for data from Jazz-sponsored clinical trials in a responsible manner that includes protecting patient privacy, assurance of data security and integrity, and furthering scientific and medical innovation. Additional details on Jazz Pharmaceuticals data sharing criteria and the process for requesting access can be found at:\n                      \n                      .","order":2,"name":"Ethics","label":"Data Availability Statement","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The EpiCom study is conducted in accordance with the consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, International Council for Harmonisation Good Clinical Practice Guidelines, and the applicable laws and regulations of the participating countries. The protocol and amendments were approved by an institutional review board or independent ethics committee and national regulatory authority (as applicable) before initiation. The protocol was approved by WCG Institutional Review Board in the United States; received a favorable opinion from South Central\u2013Oxford A Research Ethics Committee; and was approved by the Health Research Authority and Health and Care Research Wales in the UK. The protocol has also been approved by the European Union Clinical Trials Information System for Poland. Written informed consent was obtained from all participants or the participants\u2019 parent(s)\/legally authorized representatives prior to any study-related procedures.","order":3,"name":"Ethics","label":"Ethics Approval","group":{"name":"EthicsHeading","label":"Declarations"}}]}}