1. Office of New Drug IPharmaceuticals and Medical Devices Agency Tokyo Japan
2. Department of Regulatory Science of MedicineGraduate School of MedicineChiba University Chiba Japan
3. Office of Medical Informatics and EpidemiologyPharmaceuticals and Medical Devices Agency Tokyo Japan
4. Division of Clinical Research CenterChiba University Hospital Chiba Japan
5. Graduate School of MedicineNagoya University Nagoya Japan