{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.75","value":"-7.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"The change in the subject's calculated VMI from baseline to the end of treatment at 12 weeks (±1 week). VMI = 1.0 x %S + 0.5 x %I + 0.0 x %P cells, which is the same as VMI = %S + (0.5 x %I) when simplified. It has a potential range of 0-100. A VMI of 65-100 suggests a normal premenopausal environment, 50-64 indicates a moderate estrogenic effect, and \\< 50 indicates atrophy.","dispersionType":"Standard Deviation","groups":[{"description":"Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week).","id":"OG000","title":"Intrarosa & Standard of Care Aromatase Inhibitor"},{"description":"Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks (±1 week).","id":"OG001","title":"Replens & Standard of Care Aromatase Inhibitor"}],"paramType":"MEAN","populationDescription":"Out of 8 participants assigned to a treatment arm, only 2 had VMI measured at both the baseline and 12-week visits.","reportingStatus":"POSTED","timeFrame":"Baseline and 12 weeks (±1 week)","title":"Difference in Vaginal Maturation Index (VMI) Response From Baseline to Week 12","type":"PRIMARY","unitOfMeasure":"Units on a scale"}