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 3 Sensitivity analysis of handling missing data on the primary outcome

Outcome	Handling of missing data at end of trial	Events n (%)		Absolute difference between arms (n, 95%CI)	Logistic regression^a odds ratio (95% CI)
Outcome	Handling of missing data at end of trial	Intervention	Control	Absolute difference between arms (n, 95%CI)	Logistic regression^a odds ratio (95% CI)
No. of smokers^b at 16 weeks, ITT^c	Equal to baseline^d
No. of smokers^b at 16 weeks, ITT^c	Person excluded^e
No. of smokers^b at 16 weeks, PP^f	Equal to baseline^d
No. of smokers^b at 16 weeks, PP^f	Person excluded^e
At least 50% reduction number^g of cigarettes at 16 weeks, ITT	Equal to baseline^d
	Person excluded^e
At least 50% reduction number^g of cigarettes at 16 weeks, PP	Equal to baseline^d
	Person excluded^e

^aUnadjusted analysis unless Table 1 indicates 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
^dIf data on primary outcome is missing at 16 weeks, the results are set equal to baseline
^eIf data on primary outcome is missing at 16 weeks the person is excluded from the analysis (complete case)
^f PP, per protocol population: all participants who completed at least 50% of the trial visits
^gThe average daily number of cigarettes smoked, as reported by the participant

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