{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.72","value":"2.18"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"55"}],"units":"Architectural Changes"}],"title":"Average score of architectural changes at Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.90","value":"1.10"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"51"}],"units":"Architectural Changes"}],"title":"Average score of architectural changes at 3-month follow-up"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.87","value":"1.04"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"51"}],"units":"Architectural Changes"}],"title":"Average score of architectural changes at 6-month follow-up"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.91","value":"1.08"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"49"}],"units":"Architectural Changes"}],"title":"Average score of architectural changes at 12-month follow-up"}],"denomUnitsSelected":"Architectural Changes","denoms":[{"counts":[{"groupId":"OG000","value":"12"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"55"}],"units":"Architectural Changes"}],"description":"Each architectural change of VLS (labial fusion, clitoral hood fusion, narrowing of the introitus, anterior changes, perianal involvement, formation of posterior commissure bands) was assessed separately by the investigator, using a 4-point scale (0=not present, 1=mild, 2=moderate or 3=severe) for each subject at baseline and follow-ups. For those architectural changes present at baseline (baseline score \\>0 on severity scale), an average severity grade was calculated at each endpoint to evaluate overall treatment outcome, as follows:\n\nAverage severity grade = Sum of all severity grades (0, 1, 2, or 3) for each individual parameter of architectural changes present at baseline for each subject / Number of grades\n\nA lower average score means better outcome.","dispersionType":"Standard Deviation","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).","id":"OG000","title":"CO2RE® Treatment"}],"paramType":"MEAN","populationDescription":"At Baseline, 12 patients had 55 architectural changes present (score \\>0). One subject missed the 12-month follow-up, one subject missed the 3- and 12-month follow-ups and one subject missed the 6-month follow-up. Hence, at the 3- and 6-month follow-ups, 11 subjects were assessed (with 51 architectural changes averaged for each visit) and at the 12-month follow-up 10 subjects were assessed (with 49 architectural changes averaged).","reportingStatus":"POSTED","timeFrame":"Baseline, 3 , 6 and 12 months after the final treatment","title":"Average Scores for VLS Architectural Changes Present At Baseline and at 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators","type":"PRIMARY","typeUnitsAnalyzed":"Architectural Changes","unitOfMeasure":"score on a scale"}