For clinically significant values, the investigator will indicate if the value constitutes a new AE (see definition in Section 8.1.1, and record the sign, symptom, or medical diagnosis on the AE CRF), is a symptom or related to a previously recorded AE, is due to a pre- existing disease (described in Section 8.2.2), or is due to another issue that will be specified. If the abnormal value was not clinically significant, the investigator will indicate the reason, i.e., because it is due to a preexisting disease, due to a lab error, or due to another issue that will be specified. Additional tests and other evaluations required to establish the significance or etiology of an abnormal value, or to monitor the course of an AE should be obtained when clinically indicated. Any abnormal value that persists should be followed at the discretion of the investigator. The investigator will communicate the AE to the safety review team for final evaluation. 6.7.9 Patient Diary A subject dia ry will be distributed to subjects on Day 1 (Visit 2) , Day 92 ±2 (Visit 7) and Day 183 ±2 (Visit 12) to collect local signs related to the injection sites, physical fatigue, and body temperature during the first two weeks after the injection . Temperature s hould be consistently measured at the same location (e.g.