^aDepartments of Clinical Pharmacology and Therapeutics

^bPlanning for Drug Development and Clinical Evaluation, Tohoku University Graduate School of Pharmaceutical Sciences, Sendai

^cTohoku University 21st Century COE Program ‘Comprehensive Research and Education Centre for Planning of Drug Development and Clinical Evaluation’, Sendai, Japan

^*For details of the J-HOME Study Group, see [1].

Correspondence and requests for reprints to Takayoshi Ohkubo, Department of Planning for Drug Development and Clinical Evaluation, Tohoku University Hospital, Sendai 980-8574, Japan Tel: +81 22 7178590; fax: +81 22 7178591; e-mail: tohkubo@mail.tains.tohoku.ac.jp