We conducted a randomized, double-blind study comparing acamprosate with placebo in Japanese patients, the design of which differs from studies undertaken in the United States and European Union in 2 respects. First, we designed the study to reflect routine clinical practice for the treatment of alcohol dependence in Japan, which differs substantially from practice in the European Union and United States. In Japan, patients are hospitalized for about 2 months for treatment of withdrawal symptoms followed by rehabilitation therapy, with drug treatment being initiated on the day of hospital discharge. By contrast, in EU studies, patients are discharged soon after treatment for withdrawal symptoms, with drug treatment initiated upon discharge or after several days.