This noninferiority, open-label RCT was undertaken in New South Wales and Victoria, Australia. The trial was approved by the University of New South Wales human research study ethics committee (HC16888). A scientific trial alert was sent to the Australian Restorative Goods Administration (Application ID: CT-2016-CTN-04676-1). All individuals provided spoken informed approval.
Screening, consenting treatments, and check-in calls were completed by personnel at the trial coordinating center located at the University of New South Wales (the sole research study site for the trial). The RCT was carried out mainly by telephone and the research study drugs were provided by mail. To verify cytisine smoking cessation of constant smoking cessation, an in-person see was required to administer the carbon monoxide breath test.
Individuals and trial collaborating center personnel were not blinded to treatment allotment. People were hired from advertisements (print [ie, papers and posters], radio, and digital media [ie, Facebook and Google] and from a smoking cessation telephone gave up line that offered behavioral support. The research study treatments and more information on the trial style appear in the e, Figure and in the e, Approaches in Supplement 3.
Due to the considerable distinctions in smoking rates that exist in between ethnic groups in Australia, especially among the native Aboriginal and Torres Strait Islander peoples, participants were asked to self-identify which ethnic groups they belonged to through a fixed-category question. The exclusion criteria were women who were pregnant, breastfeeding, or preparing to get pregnant within the next 7 months; individuals who were currently utilizing smoking cigarettes cessation medications; those who were getting involved in another cigarette smoking cessation program; those with a recognized hypersensitivity to any of the active compounds or excipients; those with a hospitalization within the previous 3 months for arrhythmia, myocardial infarction, stroke, or extreme angina; and those with a known diagnosis of pheochromocytoma or hyperthyroidism.
Additional details on precautionary conditions for the study treatments and the screening process appear in the e, Approaches in Supplement 3. Randomization and Masking A data management system (UNICOM Intelligence) located at the social research center was utilized to designate an unique randomization number to study individuals utilizing a pregenerated randomization list embedded in the system.
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