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The WVU Arthur I. Jacknowitz Foundation Endowment Fund provided partial support for investigator\/author RCR and paid the \u2018open access fee\u2019 for our manuscript in <i>CNS Drugs<\/i> in full.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"RCR and his research efforts were supported, in part, by the WVU Arthur I. Jacknowitz Endowment Fund. RCR has acted as a consultant for Otsuka Pharmaceuticals and UCB. WER has acted as a consultant\/advisor for SK Life Science, Inc.; acted as a speaker for Eisai, Greenwich Biosciences (formerly GW Pharmaceuticals), SK Life Science, Inc., Sunovion, and UCB; and has received research support from Greenwich Biosciences, Marinus, Medtronic, Neurelis, Ovid, SK Life Science, Inc., Takeda, UCB, and Upsher-Smith. SML has received research support from Greenwich Biosciences, Marinus, Medtronic, Neurelis, Ovid, SK Life Science, Inc., Takeda, UCB, and Upsher-Smith. RMJCE has received research support from UCB for statistical analysis for this project only. DGAKNT has received research support from UCB and Otsuka Pharmaceuticals and lecture honoraria from UCB, Otsuka Pharmaceuticals, and SK Pharma.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of Interest"}},{"value":"Our protocol was reviewed and approved by Schulman and Associates, Protocol SAIRB-18\u20130016, version 1 \u20138 January 2018, Amendment 1 \u2013 6 April 2018, under the title: \u201cDoes brivaracetam (BRV) have a faster onset time and greater effect than levetiracetam (LEV) in epilepsy patients?: A prospective, randomized, crossover, double-blind, controlled intravenous study using the evoked photoparoxysmal EEG response (PPR) as a pharmacodynamic efficacy endpoint.\u201d Our letter from Schulman and Associates dated 2 May 2018, indicated our protocol (reference IRB #201802030) had full board approval on 27 April 2018, with expiration on 26 April 2019.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval"}},{"value":"Separate consent forms for parts 1 and 2 of our protocol were approved by Schulman and Associates. All patients provided written informed consent prior to any research activities being conducted (at the beginning of the screening visit).","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":"Readers are reminded that some material is available in the online Electronic Supplementary Material (ESM). All original patient records and original EEG tracings\/video files are kept by WER and SML. Final EEG analysis of original EEG data is kept by DKNT. Original statistical analysis data is kept by MJCE-(Rene). Original plasma drug concentration data, recalculated\/reformatted drug concentration data, and data sets that generated all our Tables and Figure(s) for our current study\/manuscript are kept by the Corresponding Author (RCR). Reasonable requests for data from the authors can be made at their addresses listed on the last page (Affiliations section), or via email from the corresponding author, RCR.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of Data and Material"}},{"value":"All pertinent EEG data was logged into a secured database (Access). R version 3.5.0 (R Core Team [2018]; ) was used for statistical analysis. The Satterthwaite approximation (correction method for comparison of groups of small sample size in the linear mixed model) can be found the LmerTest package in R.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of Code"}},{"value":"RCR and DGAKNT conceptualized and wrote the original study design; all authors contributed to study modifications, and the final protocol was approved by all. Two simulations\/mock runs of all study procedures were conducted by all authors (except for RMJCE) and research staff at the clinical study site (Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, MO, USA) before the screening of the first patient. The statistical plan was written by RMJCE, who also carried out the statistical interpretation and analysis. RCR and DKNT visited the clinical site on several occasions, during both parts 1 and 2, to advise on data collection and conduct quality assurance. Blinded EEG analysis, post-patient visits, was performed by DKNT. RCR performed the pharmacokinetic analysis. Material was prepared, data were collected, and patient clinic visits were conducted by WER and SML. Data were analyzed by RCR, DKNT, WER, and RMJCE. The first draft of our manuscript was written by RCR; comments and critical revisions for important intellectual content in all subsequent version(s) were made by all authors. All authors read the reviewers\u2019 and editor\u2019s comments, submitted their proposed alterations, and approved this final revised manuscript. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author Contributions"}}]}}