After acquisition of informed consent to participation in the study until the end of the final observation, if information becomes available that may be relevant to the patient's willingness to continue participation in the study, the patient will be informed in a timely manner to confirm as to whether the patient is still willing to participate in the study. This communication should be recorded in writing. At this time, if the investigator considers that the written information should be revised, the written information should be promptly revised.