Document is current

Article History

Received: 26 June 2023

Accepted: 30 August 2023

First Online: 11 September 2023

Declarations

:

: All methods are undertaken in accordance with relevant guidelines and regulations. Informed consent is obtained from all participants, using a two-step verbal consent process (documented on-line). Ethics approval was obtained on 24^th March 2022 from the Health and Disability Ethics Committee Extra Meeting Subcommittee (2022 FULL 11152). Regulatory approval for use of an unregistered medicine (Tabex®) and the nicotine e-cigarettes was obtained from the Standing Committee on Therapeutic Trials on 7^th February 2022 (2021 SCOTT 11673). The Principal Investigator will submit any protocol amendments to the Ethics Committee for review and approval prior to implementation. If an amendment substantially alters the trial design or increases the potential risk to the subject the participant information sheet and consent form will be revised and submitted to the Ethics Committee for review and approval, and participants currently enrolled in the trial, if they are affected by the amendment, will be contacted and consent re-obtained.

: Not applicable.

: All authors report grants from the Health Research Council of NZ during the conduct of the study. Drs Walker, Bullen, and Ms Parag report grants from Pfizer and the NZ Health Research Council, outside the submitted work. Drs Bullen and Walker report contracts/grants from the NZ Ministry of Health, NZ Ministry of Foreign Affairs and Trade, the US National Institute for Health, US Food and Drug Administration, USA, and the Australian National Health and Medical Research Council. Dr Bullen also reports contracts from the Auckland Council, for tobacco control research projects he is leading. Drs Walker, Bullen, Barnes and Laking, and Ms Parag have previously undertaken two trials of cytisine for smoking cessation, with non-financial support (cytisine) from Achieve Life Sciences. Drs Walker, Bullen, and Ms Parag have previously undertaken two trials of e-cigarettes for smoking cessation, with e-cigarettes purchased from a NZ e-cigarette retailer (NZVAPOR, ExternalRef removed]), e-liquid for one trial purchased from Nicopharm, Australia (ExternalRef removed) and nicotine patches supplied by the NZ Government via their contract with Novartis (Sydney, Australia). Neither NZVAPOR nor Nicopharm have links with the tobacco industry. Dr Walker reports personal fees from the Medical University of South Carolina, USA, outside the submitted work, and Dr Barnes reports reimbursement of travel expenses (for invited lectures/meetings) from Drug Safety Research Unit, UK, United States Pharmacopoeia, USA, University of Mississippi, USA, and royalties (Elsevier; Springer) outside the submitted work.