Document is current

Article History

Accepted: 3 October 2024

First Online: 25 October 2024

Declarations

:

: This research was funded by RAI Services Company, a wholly owned subsidiary of Reynolds American Inc., which is an indirect, wholly owned subsidiary of British American Tobacco plc.

: All authors are current employees of RAI Services Company. This study was funded by RAI Services Company. RAI Services Company is a wholly owned subsidiary of Reynolds American Inc., which is an indirect, wholly owned sub-sidiary of British American Tobacco p.l.c.

: The applicable data generated or analyzed during this study are included in this manuscript (and its supplementary Materials). Additional datasets access for this study is administered through an internal Data Sharing Committee on reasonable request following completion of a data sharing request form and if applicable, a Data Access Agreement. Requests for data sharing in the first instance should be emailed to the corresponding author.

: Prior to study commencement, the final protocol, the Informed Consent Form (ICF), and all other pertinent study documents were approved (approval date: 30Apr2021) by Advarra Institutional Review Board (Columbia, MD, USA), Organization number: 0000635; Registration number: 00000971). The study was conducted in accordance with the US Code of Federal Regulations (CFR) governing Protection of Human Subjects (21 CFR 50), all other applicable fed-eral regulations, and under the principles of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Guideline for Good Clinical Practice E6(R2).

: Informed consent was obtained from all subjects involved in the research prior to starting any of the research-related activities.

: Not applicable.

: Not applicable.

: Conceptualization, S.A.B. and P.M.; methodology, S.A.B. and P.M.; formal analysis, M.N.K.; investigation, K.P. and M.N.K.; resources, S.A.B.; writing—original draft preparation, M.N.K.; writing—review and editing, M.N.K., P.M., K.P., and S.A.B.; visualization, M.N.K; supervision, P.M. and S.A.B.; project administration, K.P.; funding acquisition, S.A.B. All authors have read and agreed to the published version of the manuscript.

: The authors acknowledge the expert assistance of the clinical study site (Alliance for Multispecialty Research, Knox-ville, TN USA), the contract research organization (NCGS, Charleston, NC USA), and the bioanalytical laboratory (Celerion Global Bioanalytical Services, Lincoln, NE, USA) in conducting the study. The authors also thank GL Prasad (Prasad Scientific Consulting LLC) and Ian M. Fearon (whatIF? Consulting Ltd) for assisting with manuscript preparation; Kristen G. Jordan, Megan J. Whelen, Nathan Gale, and Brian M. Keyser for critical review of the manuscript and significant contributions during manuscript preparation; Jason Hong for scientific study oversight and study design, Jenna M. Guynn for assistance with study design; Gregory P. Tarleton, PharmD, MD for providing medical expertise to ensure subject safety; Eckhardt Schmidt for bioanalytical data oversight; Peter Chen for statistical support, and Jason Henstock and Jeff Coffield for maintaining the study Trial Master File and managing other study-related documenta-tion.