deVries, Tina
Dentiste, Angela
Di Lea, Clifford
Pichette, Vincent
Jacobs, David
Funding for this research was provided by:
Osmotica Pharmaceutical US LLC
Article History
First Online: 24 July 2019
Compliance with Ethical Standards
:
: This study was funded by Osmotica Pharmaceutical US LLC. Open access fees were provided by Osmotica Pharmaceutical US LLC. Medical writing and editorial support were provided by Alicia Salinero, PhD, of AlphaBioCom, LLC (King of Prussia, PA, USA) and funded by Osmotica Pharmaceutical US LLC (Bridgewater, NJ, USA).
: Tina deVries, Angela Dentiste, and David Jacobs are employees of Osmotica Pharmaceutical US LLC and have equity interests in Osmotica Pharmaceuticals plc, the ultimate parent company of Osmotica Pharmaceutical US LLC. Clifford Di Lea is an employee of Aclairo Pharmaceutical Development Group, Inc., and received study funding from Osmotica Pharmaceutical US LLC. Vincent Pichette received funding from Algorithme Pharma to conduct part of this study.
: This study was approved by institutional review boards and conducted in compliance with Good Clinical Practice regulations and guidelines as defined by the International Conference of Harmonization. This work complies with ethical principles outlined in the US Code of Federal Regulations, Title 21, Part 50 (21CFR50), and European Union Directive 2001/20/EC. A letter of nonobjection (control number 184363) was obtained from Canadian authorities.
: All subjects signed informed consent forms after voluntarily agreeing to participate in the study.
: TD, AD, and DJ are funded by Osmotica Pharmaceutical US LLC. CD is funded by Aclairo Pharmaceutical Development Group, Inc., and Osmotica Pharmaceutical US LLC. VP received a grant from Algorithme Pharma to conduct part of this study.