Table 2. Continued

Varenicline (n=353), n (%)Placebo (n=350), n (%)Difference Between Groups, %95% CI for Difference
*AEs that began or increased in severity during treatment or up to 30 days after the last administration of the investigational product. SAEs that occurred at any time are reported. Except for the number of AEs, participants are counted only once per treatment in each row.
†Multiple AEs of the same type in an individual participant were counted only once.
‡Occurring in ≥5% of participants in either group.
§Includes all AEs reported in the MedDRA System Organ Class of Psychiatric Disorders. Each row represents a higher-level group term, which is a combination of individual symptom terms. Symptoms actually reported are in parentheses.
    Suicidal and self-injurious behaviors0 (0)0 (0)
    Change in physical activity (restlessness)3 (0.8)3 (0.9)−0.01−1.4–1.4
    Sexual dysfunction (decreased libido)2 (0.6)1 (0.3)0.3−0.7–1.2
    Delirium (confusion)1 (0.3)0 (0)0.3−0.4–1.0
    Disturbances in behavior (aggression)0 (0)1 (0.3)−0.3−1.0–0.4
    Cognitive and attention disorders00
    Dissociative disorders00
    Disturbances in thinking and perception00