1. Department of Pharmaceutical and Medical Device Regulatory Science, Graduate School of Medical Science; Yamagata University; Yamagata Japan
2. Department of Health Policy Science, Graduate School of Medical Science; Yamagata University; Yamagata Japan
3. Faculty of Pharmaceutical Sciences; Tokyo University of Pharmacy and Life Sciences; Tokyo Japan
4. Division of Epidemiology; Office of Medical informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency; Tokyo Japan
5. Kowa Co., Ltd.; Tokyo Japan