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Trends that should be carefully observed among smokers include: The use of cigarettes in place of food and/or eating Frequent cigarette breaks during and/or after meals Using cigarettes to curb cravings for certain foods Avoiding social events due to time spent smoking Any potential eating disorder behaviors observed along with cigarette use should not be ignored and help sought immediately

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This design was selected because the estimate of within-arm standard deviation (SD) from the external pilot study had a wide confidence interval and the interim analysis would allow for a more accurate estimation of the SD as a basis for assessing whether the expected effect size could be feasibly demonstrated

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