Update of statistical analysis plan for: Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR)

Table 2 Analysis and presentation of the primary outcome

Outcome	Events n (%)		Absolute difference between arms (n/%, 95%CI)	Logistic regression^a odds ratio (95% CI)
Outcome	Intervention	Control	Absolute difference between arms (n/%, 95%CI)	Logistic regression^a odds ratio (95% CI)
Smokers^b at 16 weeks, ITT^c
Carbon monoxide < 6 ppm, N (%)
Smokers at 16 weeks, PP^d
At least 50% reduction number^e of cigarettes at 16 weeks, ITT^c
At least 50% reduction number^e of cigarettes at 16 weeks, PP^d
Number of cigarettes smoked/day^c
Severe adverse events (assumed linked)

^aUnadjusted analysis unless Table 1 indicate substantial differences between arms at baseline
^bA person smoking at least one cigarette per day or seven cigarettes per week
^cITT, intention to treat population: participants assessed according to randomisation regardless of adherence to trial. Any missing data in the outcome variable will be set equal to baseline
^dPP, per protocol population: all participants who completed at least 50% of the trial visits
^eThe average daily number of cigarettes smoked, as reported by the participant

ISSN: 1745-6215