2. Patient's informed consent The investigator will hand over the written information to the patients and give an explanation of the contents of the study. The patients should be provided with ample time and opportunity to inquire about details of the study, and after confirmation that the patients fully understood the contents of the study, the informed consent form to participation in the study should be signed. (The informed consent form should describe the explanatory considerations specified in Ethical Guidelines for Clinical Studies, Part IV: Informed consent <detailed rule>) Prior to a patient's participation in the study, the written informed consent form should be signed or placed the name/seal, and personally dated by both the investigator and the patient. When CRC performed a supplemental explanation, he/she should also sign or place the name/seal, and date the informed consent form. The investigator will distribute a copy of the signed informed consent form and written information to the patient.