{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"8"}],"units":"Participants"}],"description":"A treatment emergent adverse event (TEAE) related to study drug was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, that was determined to be related to the study drug. A TEAE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. Any worsening (i.e., any clinical significant adverse change in frequency and/or intensity) of a preexisting condition, which was temporally associated with the use of the sponsor's medicinal (investigational) product, was also a TEAE. The number of participants with at least one TEAE are reported. Treatment emergent adverse events were assessed by the investigator as possibly, probably, or definitely related to the study drug.","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 to termination visit on Day 169","title":"Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug","type":"PRIMARY","unitOfMeasure":"Participants"}