{"denoms":[{"counts":[{"groupId":"BG000","value":"12"}],"units":"Participants"}],"groups":[{"description":"All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen.\n\nThe CO2RE® System: The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for treatment of leukoplakia (vulvar dystrophies).","id":"BG000","title":"CO2RE® Treatment"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"10"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"10","value":"56.6"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"Years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"12"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"11"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"10"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"12"}]}],"title":"United States"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"10.1","value":"13.9"}]}]}],"description":"The validated Female Sexual Function Index (FSFI) was used to compare sexual function to baseline. FSFI score, a 19-item validated questionnaire assesses domains of sexual function, including desire, arousal, lubrication, orgasm, satisfaction, and pain, in addition to providing an overall score regarding sexual function. The aggregated FSFI score is a sum of weighted answers for each of the 19 items in the questionnaire with a maximum score 36.0 (high level of sexual functional) and minimum score of 2.0 (low level of sexual functional).","dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"FSFI","unitOfMeasure":"score on a scale"}],"populationDescription":"Although 14 subjects enrolled, 1 subject was withdrawn from the study due to a protocol violation and 1 subject was found to be not eligible prior to her first treatment. Both are not included in the Results analysis."}