Funding for this research was provided by:
AMAG Pharmaceuticals (N/A)
Received: 17 February 2020
Accepted: 24 August 2020
First Online: 8 October 2020
Ethics approval and consent to participate
: This study was conducted in accordance with Good Clinical Practice requirements, as described in guidelines of the International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) and in the Declaration of Helsinki. Each study site was reviewed by a central or local institutional review board or ethics committee. Before any study procedures were initiated, written informed consent was obtained from each subject.
: Not applicable.
: DAR was an employee of Evidera at the time of the study, and the company received funding from Palatin Technologies, Inc.; DAR has received consulting fees and research support from Palatin Technologies, Inc., Viveve Medical, and AMAG Pharmaceuticals, Inc.SEA has served on advisory boards and has been a consultant for AMAG Pharmaceuticals, Inc., Palatin Technologies, Inc., Ixchelsis, Promescent, Strategic Science Technologies, and Valeant/Sprout. He has been a principal investigator for Clinical Outcomes Solutions, Endoceutics, and Ixchelsis, and he has served on the speakers’ bureau for Valeant.LRD has no conflicts of interest to disclose.SAK has served on advisory boards or has been a consultant for AMAG Pharmaceuticals, Inc., Astellas Pharma US, Inc., Duchesnay, Emotional Brain, Endoceutics, Ivix, Pfizer, Shionogi, Materna, TherapeuticsMD, SST, Lupin Pharmaceuticals, Inc., Palatin Technologies, Inc., and Sprout Pharmaceuticals, Inc. She has stock options in Viveve Medical.HW was an employee of Evidera, which has received funding from Palatin Technologies, Inc., at the time of the study.AS and JK are employees and stockholders of AMAG Pharmaceuticals, Inc.RJ is an employee and a stockholder of Palatin Technologies, Inc.JL was an employee of Palatin Technologies, Inc. at the time of the study.