Minkowitz, Harold
Salazar, Hernan
Leiman, David
Solanki, Daneshvari
Lu, Lucy
Reines, Scott
Ryan, Michael
Harnett, Mark http://orcid.org/0000-0002-4652-3398
Singla, Neil
Funding for this research was provided by:
Avenue Therapeutics
Article History
First Online: 14 May 2020
Compliance with Ethical Standards
:
: This study was funded in full by Avenue Therapeutics, Inc.
: All authors were either compensated directly (via salary or consulting fees) or indirectly (through employment within an organization that was paid directly by the Sponsor).
: The study was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with International Council for Harmonization (ICH)/Good Clinical Practice (GCP) guidelines, applicable regulatory requirements, and the Sponsor or its delegate’s policy on Bioethics. Aspire institutional review board (Santee, CA) performed a review of the study protocol and informed consent forms. All patients provided signed informed consent prior to participation.
: The study was registered at ClinicalTrials.gov (December 13, 2018; trial number NCT03774836), with the first patient enrolled on December 14, 2018 and the last patient completing the study on May 6, 2019.
: All authors consent for this manuscript to be published.