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Article History

First Online: 25 September 2017

Compliance with Ethical Standards

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: The single-dose study was sponsored by Cephalon, Inc., now a wholly owned subsidiary of Teva Branded Pharmaceutical Products R & D, Inc. (Frazer, PA, USA); the modeling and simulation were performed by Learn and Confirm Inc. (St-Laurent, QC, Canada), sponsored by Teva Branded Pharmaceutical Products R & D, Inc. The multiple-dose study was sponsored by Teva Branded Pharmaceutical Products R & D, Inc.

: Mary Bond, Laura Rabinovich-Guilatt, Sally Selim, William Tracewell, Philmore Robertson Jr, Ronghua Yang, and Ofer Spiegelstein are employees of Teva Branded Pharmaceutical Products R & D, Inc. Philippe Colucci and Murray P. Ducharme are employees of Learn and Confirm Inc. At the time of the single-dose study, Richard Malamut was an employee of Teva Pharmaceuticals, and Mona Darwish was an employee of Cephalon, Inc.

: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. Both studies reported here were approved by the site’s institutional review board (IntegReview, Austin, TX, USA) and conducted in full accordance with the Good Clinical Practice: Consolidated Guidelines approved by the International Conference on Harmonisation.

: Informed consent was obtained from all individual participants included in the studies.