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Table 7 Primary and secondary efficacy criteria: complete or partial abstinence during the 28 days preceding the 6-week visit (adopted from [17])

From: Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell®)

Group\Statistical results

Nicotinell®

lozenge 1 mg

Placebo

 

(n = 211)

(n = 222)

Complete abstinence (%)

48 (23%)

32 (14%)

OR [95% CI]

1.72 [1.05–2.80]

Statistical significance

p = 0.03

Complete or partial abstinence (%)

68 (32%)

39 (18%)

OR [95% CI]

2.18 [1.40–3.41]

Statistical significance

p = 0.001

  1. Complete abstinence = subjects declaring not to smoke + exhaled-breath CO <10 ppm. Partial abstinence = subjects smoking ≤ 1 cigarette/day and ≤ 7 cigarettes/week + exhaled-breath CO <10 ppm.