1. Clinical Data Science and Quality Management Department; Toray Industries, Inc.; Tokyo Japan
2. Graduate School of Science and Engineering; Chuo University; Tokyo Japan
3. Biostatatistics, Data Science Department, Ikuyaku Integrated Value Development Division; Mitsubishi Tanabe Pharma Corporation; Tokyo Japan
4. Department of Biostatistics, Graduate School of Medicine; Yokohama City University; Yokohama Japan
5. Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health; Kyoto University; Kyoto Japan
6. Clinical Research Center; Chiba University Hospital; Chiba Japan