{"denomUnitsSelected":"Participants","description":"An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.","reportingStatus":"NOT_POSTED","timeFrame":"Up to ~64 months","title":"Number of Participants Who Experience an Adverse Event (AE)","type":"SECONDARY"}