{"denomUnitsSelected":"Participants","description":"An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced at least one AE were reported .","reportingStatus":"NOT_POSTED","timeFrame":"Up to approximately 28 months","title":"Number of Participants Who Experienced at Least One Adverse Event (AE)","type":"SECONDARY"}