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Article History

Received: 20 January 2023

Accepted: 20 June 2023

First Online: 13 July 2023

Declarations

:

: This study was conducted following the Declaration of Helsinki. As per current legislation, the competent IRB (Comitato Etico Catania 2) approved the study protocol (n. 73/2020/CECT2). Informed consent was obtained from all individual participants included in the study.The study was carried out in accordance to the Principles of Good Clinical Practice (GCP) and the ethical principles set forth in the Declaration of Helsinki. The local ethical review board of the Azienda Ospedaliero Universitaria Policlinico-Vittorio Emanuele (part of the Hospital Trust of Università di Catania) reviewed and approved the study protocol. All participants provided written informed consent prior to participate in the trial.

: All participants provided written informed consent before participating in the study. In addition, consent was provided by participants for the use of data and results for publication.

: RP is full tenured professor of Internal Medicine at the University of Catania (Italy) and Medical Director of the Institute for Internal Medicine and Clinical Immunology at the same University. He has received grants from U-BIOPRED and AIR-PROM, Integral Rheumatology & Immunology Specialists Network (IRIS), Founda- tion for a Smoke Free World, Pfizer, GlaxoSmithKline, CV Therapeu- tics, NeuroSearch A/S, Sandoz, Merk Sharp & Dohme, Boehringer Ingelheim, Novartis, Arbi Group Srl., Duska Therapeutics, Forest Laboratories and Ministero dell Universita’ e della Ricerca (MUR) Bando PNRR 3277/2021 (CUP E63C22000900006) and 341/2022 (CUP E63C22002080006), funded by NextGenerationEU, the European Union (EU) economic recovery package. He is founder of the Center for Tobacco Prevention and Treatment (CPCT) at the University of Catania and of the Center of Excellence for the Acceleration of Harm Reduction at the same uni- versity. He receives consultancy fees from Pfizer, Boehringer Ingel- heim, Duska Therapeutics, Forest Laboratories, CV Therapeutics, and Sermo Inc. He is being paid textbook royalties from Elsevier. He is also involved in a patent application for ECLAT Srl. He is a pro bono scientific advisor for Lega Italiana Anti Fumo (LIAF) and the Interna- tional Network of Nicotine Consumers Organizations (INNCO); and he is Chair of the European Technical Committee for Standardization on “Requirements and test methods for emissions of electronic cigarettes” (CEN/TC 437; WG4).The other authors declare that they have no conflict of interest.