Document is current

Article History

Accepted: 21 November 2021

First Online: 18 December 2021

Declarations

:

: The study was supported by British American Tobacco (Investments) Limited, the manufacturer of Lyft and Velo smokeless oral nicotine pouches.

: All authors are current employees of British American Tobacco (Investments) Limited except JM who is an employee of RAI Services Company and IMF who is a consultant contracted by British American Tobacco (Investments) Limited.

: The study was conducted in compliance with the study protocol, the Declaration of Helsinki, the International Council for Harmonisation (ICH) Guideline E6 for Good Clinical Practice (GCP), the Food and Drug Administration (FDA) GCP Code of Federal Regulations Title 21 (part 56) and the European regulation EU 536/2014, including regulations relating to the protection of subjects’ personal data. Approval was given by an independent ethics committee (Central Swedish Ethics Committee, Uppsala, Sweden; reference number 2019-06294) prior to study commencement.

: Written informed consent was obtained from all subjects prior to participation in the study and before undergoing any study procedures, including screening assessments.

: Patients signed an informed consent regarding the publishing of their data.

: Data for this study are available on request.

: Code for this study are available on request.

: MM was the study lead, designed the study and edited the manuscript; DA was study support, designed the study and edited the manuscript; NG and GH assisted with the design of the study; OC assisted with the design of the study and designed the statistical approach; IF wrote the main manuscript text; and JM conceived the study. All authors reviewed the manuscript.