1. Office of Pharmacovigilance II, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
2. Office of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
3. Office of Regulatory Science Research, Center for Regulatory Science, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
4. Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
5. Center for Regulatory Science, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan