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Such results demonstrate the importance of studying discontinuation and success processes together.
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The SAEs of emergent mania led to study discontinuation in two patients in the add-on lithium and six patients in the add-on placebo group.
No AEs led to study discontinuation.
Their data were used for analyses up to study discontinuation.
No UTIs were serious or led to study discontinuation in patients ≥65 years of age.
AEs and serious AEs (SAEs) leading to study discontinuation were balanced across treatment groups (Table 1).
Intention-to-treat analysis will be used to prevent participant selection bias due to study discontinuation.
All AEs leading to study discontinuation occurred in the 800-mg cohort.
Adverse events leading to study discontinuation included pulmonary embolism (n = 3) and fatigue (n = 2).
The frequency of AEs leading to study discontinuation was low among subgroups.
All TEAEs were graded as mild or moderate, and none led to study discontinuation during either study phase.
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