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Article History

First Online: 2 May 2019

Compliance with Ethical Standards

:

: The study protocol and amendments were approved by an institutional review board/ethics committee at each participating study center.

: All patients and/or parent(s)/caregiver(s) provided written informed consent and assent (as applicable) at enrollment.

: This study was supported by INSYS Development Company, Inc. Support for technical editorial and medical writing assistance was provided by INSYS Development Company, Inc. Support for Open Access for this publication was provided by INSYS Development Company, Inc.

: James W. Wheless reports that his institution received research funding from Acadia Pharmaceuticals Inc., GW Pharmaceuticals, plc., INSYS Development Company, Inc., LivaNova, Mallinckrodt, National Institutes of Health, Neurelis, Inc., NeuroPace, Inc., Shainberg Foundation, Upsher-Smith Laboratories, LLC, and Zogenix, Inc.; and has been a consultant and/or on speaker’s bureaus for CombiMatrix, Eisai Co., Ltd., GW Pharmaceuticals, plc., LivaNova, Lundbeck, Mallinckrodt, NeuroPace, Sun Pharmaceutical Industries, Ltd., Supernus Pharmaceuticals, Inc., and Upsher-Smith Laboratories, LLC. Dennis Dlugos reports that he received salary support from the National Institutes of Health, the Commonwealth of Pennsylvania Department of Health, and the Epilepsy Study Consortium, and he also received research program support for pre-study protocol development agreements with Bio-Pharm Solutions Inc., INSYS Development Company, Inc., and UCB, Inc. His institution received research support for clinical trials from INSYS Development Company, Inc. Ian Miller received honoraria and travel support from INSYS Development Company, Inc. and reports that his institution received study funding from INSYS Development Company, Inc. D. Alexander Oh was an employee of INSYS Development Company, Inc. and owns stock options for INSYS Development Company, Inc. Neha Parikh is an employee of INSYS Development Company, Inc. and owns stock options for INSYS Development Company, Inc. Steven Phillips reports that his institution received study funding from INSYS Development Company, Inc. J. Ben Renfroe reports that his institution received study funding from INSYS Development Company, Inc. Colin M. Roberts reports that his institution received study funding from INSYS Development Company, Inc. Isra Saeed reports that her institution received funding from INSYS Development Company, Inc. Steven P. Sparagana reports that his institution received study funding from INSYS Development Company, Inc. Jin Yu is an employee of INSYS Development Company, Inc. and owns stock options for INSYS Development Company, Inc. Maria Roberta Cilio reports that her institution received research support for clinical trials from INSYS Development Company, Inc; she also has been a consultant for BioMarin Pharmaceutical Inc., GW Pharmaceuticals plc., and Xenon Pharmaceuticals; and she received administrative support paid to her institution and drugs free of charge from GW Pharmaceuticals for previous studies.