Security assessment
CRF
EVENTS, CRF
Examination of AEs and clinical endpoints will begin with randomization and will continue to focus on individual patients until they complete a 14-week follow-up. At each visit, the investigator or designee will conduct a safety assessment and will specifically review the clinical history associated with the occurrence of AEs or SAEs and their causal relationship to the test drug to assess the severity of the AEs. Details of AEs and clinical events will be recorded in the CRF, regardless whether the AE is related to the test drug. All AEs should be tracked for follow-up until the incident is resolved.