1. Japan Safety and Surveillance Division, Research and Development Division, Janssen Pharmaceutical K.K., Tokyo, Japan;
2. Data Management Department, Research and Development Division, Janssen Pharmaceutical K.K., Tokyo, Japan;
3. Biostatistics Department, Research and Development Division, Janssen Pharmaceutical K.K., Tokyo, Japan;
4. Medical Affairs Division, Janssen Pharmaceutical K.K., Tokyo, Japan;
5. Hakkeikai Incorporated Medical Institution/Department of Orthopaedic Surgery, Keio University, Shizuoka, Japan;
6. Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan