Perera, Vidya http://orcid.org/0000-0002-9055-0123
Abelian, Grigor
Li, Danshi
Wang, Zhaoqing
Zhang, Liping
Lubin, Susan
Bello, Akintunde
Murthy, Bindu
Funding for this research was provided by:
Bristol Myers Squibb
Article History
Accepted: 15 June 2022
First Online: 30 July 2022
Declarations
:
: This study was conducted in accordance with Good Clinical Practice, as defined by the International Council for Harmonisation and in accordance with the ethical principles underlying European Union Directive 2001/20/EC and the United States Code of Federal Regulations, Title 21, Part 50 (21CFR50). The study was registered with ClinicalTrials.gov (NCT03196206, first posted 22 June 2017). The protocol, amendments, and participant informed consent received appropriate approval by the IEX and the IRB of IntegReview IRB (now Advarra; Columbia, MD, USA) prior to initiation of the study at the site. The study was conducted at two clinical sites (Clinical Pharmacology of Miami LLC, Miami, FL, USA; and Orlando Clinical Research Center, Orlando, FL, USA) from 6 July 2017 to 4 March 2018.
: Prior to the beginning of the study, all participants provided written informed consent, including consent for any screening procedures conducted to establish participant eligibility for the study.
: Not applicable.
: The data that support the findings of this study are not publicly available due to privacy or ethical restrictions. Please contact the corresponding author, Vidya Perera, for additional information.
: Not applicable.
: VP, GA, DL, ZW, SL, AB, and BM are full-time employees of Bristol Myers Squibb. LZ is a full-time employee of Janssen.
: This study was sponsored by Bristol Myers Squibb.
: VP, GA, DL, ZW, LZ, SL, AB, and BM contributed to the study design and concept, data analysis and review, or data interpretation; critically reviewed the manuscript for intellectual content; and approved the final manuscript for publication.