Landy, Stephen
Munjal, Sagar
Brand-Schieber, Elimor
Rapoport, Alan M.
Article History
Received: 23 April 2018
Accepted: 2 July 2018
First Online: 15 August 2018
Ethics approval and consent to participate
: The protocol of this randomized, double-blind, placebo-controlled study was approved by the institutional review boards at each study site, and the study was conducted in compliance with good clinical practice and in accordance with the ethical principles set forth in the Declaration of Helsinki. Before any study-specific procedures were initiated, investigators explained the nature of the study to the subjects, and subjects provided informed consent.
: Not applicable.
: This study was supported and funded by the Dr. Reddy’s Laboratories group of companies, Princeton, NJ, manufacturer of DFN-11. SM and EBS are employed by and own stock in Dr. Reddy’s Laboratories Ltd. SL and AMR are paid consultants of Dr. Reddy’s Laboratories Ltd., but they were not paid to draft or edit this paper. SL also serves on the speaker’s bureau of Allergan, Amgen, Depomed, ElectroCore, Promius Pharma, and Supernus; he is a consultant for Allergan, Amgen, Promius Pharma, and Supernus. AMR is also on the speaker’s bureau of Amgen, Avanir, Depomed, Promius Pharma and Teva; he is a consultant for Amgen, Autonomic Technologies, Depomed, ElectroCore, Impax, Pernix, Teva, and Zosano.
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