1. Office of New Drug V, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
2. Office of Medical Devices I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
3. Office of Research Promotion, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
4. Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
5. Center for Regulatory Science, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan