Ayad, Sabry http://orcid.org/0000-0002-6728-9297
Demitrack, Mark A.
Burt, David A.
Michalsky, Cathy
Wase, Linda
Fossler, Michael J.
Khanna, Ashish K.
Funding for this research was provided by:
Trevena, Inc.
Article History
First Online: 24 June 2020
Compliance with Ethical Standards
:
: The studies included here in the exploratory analyses (hard tissue (bunionectomy, APOLLO-1); NCT02815709 and soft tissue (abdominoplasty, APOLLO-2)) NCT02820324 were sponsored by Trevena, Inc. The post hoc analysis described here was also funded by Trevena, Inc. The funding for open-access was provided by Trevena, Inc.
: Mark A. Demitrack, Cathy Michalsky, Linda Wase, and Michael J. Fossler are full-time employees and stockholders of Trevena Inc. At the time the research was conducted, David A. Burt was the key statistician employed at Trevena, Inc. Sabry Ayad and Ashish K. Khanna have nothing to disclose.
: At the time of preparation and submission of this manuscript, oliceridine, an investigational IV opioid, was not yet approved by the US Food and Drug Administration or any other governmental agencies.
: All procedures performed in the studies were conducted in accordance with the International Conference on Harmonisation Good Clinical Practice guidelines and ethical principles that have their origin in the Declaration of Helsinki. Protocols were approved by an Independent Ethics Committee before eligibility screening.
: Informed consent was obtained from all individual participants included in the study, as specified in the APOLLO-1 and APOLLO-2 studies.