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Table 1 Cytisine and smoking relapse trial objectives

From: Cytisine compared to combination nicotine replacement therapy to reduce cigarette consumption in relapsed smokers: protocol for a pilot randomized controlled trial

Primary objective

 (a) To evaluate the feasibility of future randomized clinical trial about effect of cytisine for prevent smoking cessation relapse among cardiovascular disease (CVD) patients who smoke daily

Secondary objectives

 (b) To recruit 10 relapsed smokers with CVD per month to a study of cytisine vs. combination NRT

 (c) To assess any differences in the effectiveness of the form of tobacco used (tobacco smoking only versus a combination of smoking and smokeless tobacco)

 (d) To assess any differences in the effect across different CVD severity groups, high and low socio-economic status (SES), gender, and age subgroups

 (f) To assess possible adverse effects of cytisine in the target population

 (g) To assess all relevant components of the design and delivery of the smoking cessation program as part of a process evaluation