{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"8"}],"units":"Participants"}],"description":"A Serious Adverse Event (SAE) was defined as any untoward medical occurrence that at any dose (including overdose) that was fatal, was life threatening, required or prolonged inpatient hospitalization, resulted in permanent or significant disability/incapacity, or was a congenital anomaly/birth defect. The number of participants with at least one serious adverse event are reported.","groups":[{"description":"Placebo was administered within 28 days of screening. Subsequent doses were administered every 28 days for a total of four doses.","id":"OG000","title":"Placebo"},{"description":"0.1 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169).","id":"OG001","title":"0.1 mg/kg ACE 011"},{"description":"0.3 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169)","id":"OG002","title":"0.3 mg/kg ACE 011"},{"description":"0.5 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169).","id":"OG003","title":"0.5 mg/kg ACE 011"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"From first dose up to termination visit on Day 169","title":"Number of Participants With Serious Adverse Events (SAEs)","type":"PRIMARY","unitOfMeasure":"Participants"}