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The collection of harms was well reported (maximum quality score) and showed higher frequency of nausea for rivastigmine than donepezil during the titration phases.

This analysis included both those who completed the study and those who discontinued their assigned treatment prematurely.

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Following a general rule required by the Japanese regulatory authority in those days, Japan independently conducted Phase II dose-finding studies and Phase III confirmatory studies, as well as a study to evaluate the safety of long-term treatment and proved efficacy and safety in Japanese patients.

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In these studies, animals were randomly assigned to receive intrathecal saline, the nicotinic antagonist mecamylamine, 50 μg, or a combination of this dose of mecamylamine and atropine, 3 μg, 30 min after oral donepezil, and withdrawal threshold was determined 30 min later (1 h after donepezil).

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