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Article History

First Online: 30 April 2020

Compliance with Ethical Standards

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: The sponsor adheres to current requirements of the USA and the EU so will not make individual de-identified participant data available; however, the protocol and statistical analysis plan will be made available upon request to the corresponding author.

: Open access funding provided by Greenwich Biosciences, Inc. This trial was sponsored by GW Research Ltd, Cambridge, UK.

: Elinor Ben-Menachem has received consulting honoraria from GW Pharmaceuticals companies, UCB, Sandoz, Eisai, and Bial and has been a principal investigator for GW Research Ltd. Boudewijn Gunning has received consultancy fees from GW Pharmaceuticals companies, Zogenix, and Ovid/Takeda; has been a principal investigator for GW Research Ltd, Zogenix, LivaNova, Marinus Pharmaceuticals, and UCB; and is a member of the International Speakers Bureau of LivaNova. Carmen María Arenas Cabrera has received consultancy fees from UCB, Eisai, Bial, and Esteve and has been a principal investigator for GW Research Ltd. Kevan VanLandingham is employed by Greenwich Biosciences, Inc. and owns shares in GW Pharmaceuticals plc. Bola Tayo and Gilmour Morrison are employed by GW Research Ltd and own shares in GW Pharmaceuticals plc. David Critchley, Louise Wray, and Julie Crockett are employed by GW Research Ltd and have share options in GW Pharmaceuticals plc. Manuel Toledo has received consulting honoraria and lecture fees from GW Pharmaceuticals companies, UCB Pharma, Eisai, Bial, Esteve, and Sanofi and has been a principal investigator for GW Research Ltd.

: The protocol and informed consent forms were approved by local independent ethics committees. All procedures performed in studies involving human participants were in accordance with the International Council for Harmonisation Good Clinical Practice Consolidated Guideline, the applicable local laws and regulatory requirements of the countries in which the trial was conducted, and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

: Written informed consent/assent was obtained from all individual patients included in the trial (or their parent/legal representative) before any trial-specific procedures were performed or any patient-related data were collected.