Efficacy and safety of donepezil in patients with dementia with Lewy bodies: results from a 12-week multicentre, randomised, double-blind, and placebo-controlled phase IV study.

Even though the phase IV study was conservatively designed to verify the efficacy of donepezil under the situation where only the phase II data were available to estimate the effect size of CIBIC‐plus for DLB patients, the primary endpoint in the phase IV study did not reach statistical significance.

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