Funding for this research was provided by:
Health Research Council of New Zealand (16/066)
Oakley Mental Health Research Foundation
Text and Data Mining valid from 2018-05-04
Received: 6 December 2017
Accepted: 21 March 2018
First Online: 4 May 2018
Ethics approval and consent to participate
: The study was approved on 07/11/2016 by the NZ Southern Health and Disability Ethics Committees (reference 16/STA/153). Two subsequent amendments to the study protocol were approved on 4/09/2017 and 8/12/2017 and ethics approval for all further amendments to the study protocol will be sought, prior to implementation of the changes (information on the trial registry will be updated accordingly). Maintenance of confidentiality and compliance with NZ’s Privacy Act will be emphasised to all study participants. Participation in the study will be entirely voluntary. Both verbal and written consent (Additional file InternalRef removed) will be obtained from all participants at various times as they move through the study. All data will be entered, stored and backed-up in a secure manner via an internet data management system. If any participants suffer harm from trial participation (which is unlikely), they should be eligible for compensation via their private health or life insurance, or via NZ’s Accident Compensation Corporation (ACC) scheme.
: No identifiable individual participant data (names or other personal identifiers) are contained in this manuscript.
: No authors have received financial support from any companies for the submitted work. NW, CB, VP, and MV have received smoking cessation medication and matching placebo from Pfizer, for the conduct of a relapse prevention trial in COPD patients who smoke. CB has previously undertaken research funded by NicoNovum prior to its sale to RJ Reynolds. CB received benefits in kind (accommodation expenses) from a manufacturer of smoking cessation medications. NW has provided consultancy to the manufacturers of smoking cessation medications, received honoraria for speaking at a research meeting and received benefits in kind and travel support from a manufacturer of smoking cessation medications. MV has previously undertaken research supported by an unrestricted grant from Pfizer. All authors, CB, NW, VP and GL were involved in a previous trial investigating the effect of ECs on smoking cessation. All authors’ spouses, partners, or children have no financial relationships that may be relevant to the submitted work. All authors have no non-financial interests that may be relevant to the submitted work.
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