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Parviz Ghahramani and Tatiana Khariton were employees of Forest Research Institute, Inc., an Allergan affiliate, at the time of the study. Parviz Ghahramani is currently employed by Inncelerex. Margit Kap\u00e1s is an employee of and stockholder in Gedeon Richter Plc. Cognigen Corporation, a Simulations Plus Company, was contracted to perform the analysis; Luann Phillips is an employee of Cognigen Corporation.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All clinical trials described in this study were in accordance with the 1964 Helsinki declaration (and its amendments), and the details of the Ethics Committee or institutional review board which approved the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Written informed consent was obtained from all patients before enrollment. The authors all consent to have this manuscript published in the journal.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"Qualified researchers engaged in rigorous, independent scientific research can request access to our clinical trial data. Access will be provided following receipt of a research proposal and Statistical Analysis Plan (SAP), review of the proposal and SAP and execution of a Data Use Agreement (DUA).","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Cognigen will share selected NONMEM codes as related to this analysis. To request access, the researcher must sign a code use agreement that states the researcher will not use the code for any commercial purposes.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"AP, LP, PG, MK, TC, and TK wrote the manuscript, designed the research, and analyzed the data. LP performed the research (modeling).","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}