{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"81"},{"groupId":"OG001","value":"26"}],"units":"Participants"}],"description":"Using the Numerical Rating Score (NRS) for pain (0 being no pain and 10 being worst imaginable pain), each subject was rated as a Responder or Non-responder. A responder is defined as a subject with a reduction in NRS worst score from baseline of two (2) or more points, and no increase in pain medication use.","groups":[{"description":"ExAblate 2000: MR guided focused ultrasound","id":"OG000","title":"ExAblate Treatment Arm"},{"description":"ExAblate 2000: MR guided focused ultrasound sham","id":"OG001","title":"ExAblate Sham Control Arm"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"115 subjects were underwent treatment. Of these, 4 subjects terminated treatment prior to full completion. These 4 subjects are excluded from the efficacy analysis. An additional 4 subjects were found to have been enrolled in the study more than once. In a pre-PMA meeting with FDA, it was agreed upon to exclude these 4 subjects from the analysis.","reportingStatus":"POSTED","timeFrame":"3 months post treatment","title":"Number of Responders","type":"PRIMARY","unitOfMeasure":"Participants"}