{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.73","value":"1.85"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"96"}],"units":"Clinical signs"}],"title":"Average score of clinical signs at Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.74","value":"0.65"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"89"}],"units":"Clinical signs"}],"title":"Average score of clinical signs at 3-months follow-up visit"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.76","value":"0.65"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"89"}],"units":"Clinical signs"}],"title":"Average score of clinical signs at 6-months follow-up visit"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.83","value":"0.73"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"79"}],"units":"Clinical signs"}],"title":"Average score of clinical signs at 12-months follow-up visits"}],"denomUnitsSelected":"Clinical signs","denoms":[{"counts":[{"groupId":"OG000","value":"12"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"96"}],"units":"Clinical signs"}],"description":"Each clinical sign of VLS (loss of elasticity, sclerosis, lichenification, whitening, parchment-like skin, fissures, extent of the disease, erosions, ulcerations, hyperkeratosis, excoriation, telangiectasia) 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 clinical signs 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 clinical signs 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 subjects had 96 clinical signs 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 3- and 6-month follow-up visits 11 subjects were assessed (with 89 clinical signs averaged for each visit) and at the 12-month follow-up visit 10 subjects were assessed (with 79 clinical signs averaged).","reportingStatus":"POSTED","timeFrame":"At Baseline, 3, 6 and 12 months after the final treatment","title":"Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators","type":"PRIMARY","typeUnitsAnalyzed":"Clinical signs","unitOfMeasure":"score on a scale"}