{"denoms":[{"counts":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"8"}],"units":"Participants"}],"groups":[{"description":"Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week).","id":"BG000","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":"BG001","title":"Replens & Standard of Care Aromatase Inhibitor"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"3.96","value":"57.8"},{"groupId":"BG001","spread":"15.39","value":"54.00"},{"groupId":"BG002","spread":"8.98","value":"56.38"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"8"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"6"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"8"}]}],"title":"United States"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Region of Enrollment","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"16.65","value":"50.83"},{"groupId":"BG001","spread":"23.23","value":"36.67"},{"groupId":"BG002","spread":"19.67","value":"43.75"}]}]}],"description":"VMI is a clinical measure of vaginal estrogenization, indicator of the degree of vaginal atrophy which is the end result of treatment with aromatase inhibitors that leads to vaginal dryness and dyspareunia. VMI is the proportional relationship of parabasal (P) cells to intermediate (I) and superficial (S) cells in the vaginal epithelium. VMI = 1.0 x %S + 0.5 x %I + 0.0 x %P cells, which is VMI=%S + (0.5 x %I) when simplified, 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","paramType":"MEAN","title":"Vaginal Maturation Index (VMI)","unitOfMeasure":"Units on a scale"}],"populationDescription":"Postmenopausal females between 18 and 70 with a history of breast cancer."}