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Article History

Received: 14 December 2023

Accepted: 14 November 2024

First Online: 23 November 2024

Declarations

: The study was conducted by CTC Clinical Trial Consultants AB under contract to JTI in accordance with ethical principles that have their origin in the Declaration of Helsinki, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 (R2) guideline for Good Clinical Practice (GCP), as well as the European Union (EU) Clinical Trials Directive 2001/20/EC. The participants’ personal data was protected in accordance with the EU General Data Protection Regulation (GDPR) 2016/679. The study was approved by a competent authority (Swedish Medical Products agency approval no. 5.1–2020-60886) and an independent ethics committee (Swedish Ethical Review Authority approval no. 2020–05745) prior to study initiation. All participants in the study reviewed, signed, and dated an informed consent form prior to study initiation.

: During the study, D.N. was employed by Japan Tobacco Inc., and K.R., S.L., L.G. and J.M. were employed by JT International SA. J.N. was employed by CTC Clinical Trial Consultants AB and was the Principal Investigator of the study.