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Although no substantive differences were observed between the placebo- and keppra-treated groups in the median change from baseline in this battery, the study was not adequate to assess formal statistical non-inferiority between the drug and placebo.
The safety and effectiveness of keppra as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in pediatric patients 6 years of age and older with idiopathic generalized epilepsy have been established see clinical studies 14.
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In the keppra xr double-blind, controlled trial in patients experiencing partial onset seizures, 8 of keppra xr-treated patients experienced somnolence compared to 3 of placebo-treated patients.
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