Liu, Jianmin
Rensch, Jesse
Wang, Jingzhu
Jin, Xiaohong
Vansickel, Andrea
Edmiston, Jeffery
Sarkar, Mohamadi
Funding for this research was provided by:
Altria Client Services LLC
Article History
Received: 26 October 2021
Accepted: 1 June 2022
First Online: 23 July 2022
Declarations
: This study was funded by Altria Client Services LLC, and all authors are employees of Altria Client Services LLC. The Advarra Institutional Review Board (IRB) (Columbia, MD) reviewed and approved this study. The study was conducted in accordance with Food and Drug Administration (FDA) regulations as described in the Code of Federal Regulations (CFR) 21 Parts 50 and 56, Department of Health and Human Services regulations as described in 45 CFR 46, guidelines resulting from the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP), the European Union (EU) directive 2001/20/EC, and the ethical principles set forth in the Declaration of Helsinki. In addition, the IRB operates in compliance with the portions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA Privacy Rule) that apply to research, as described in 45 CFR Parts 160 and 164. All participants in this study reviewed, signed, and dated the informed consent form prior to study initiation.
: The authors are employees of Altria Client Services LLC.