{"denomUnitsSelected":"Participants","description":"An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.","reportingStatus":"NOT_POSTED","timeFrame":"Up to approximately 7.6 years","title":"Number of Participants Experiencing Adverse Events (AEs)","type":"SECONDARY"}