{"analyses":[{"groupDescription":"Change in total score of signs between week 3 and baseline","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"<0.001","statisticalMethod":"Wilcoxon (Mann-Whitney)"},{"groupDescription":"Change in total score of signs between week 12 and baseline","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"<0.001","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.0","upperLimit":"5.0","value":"4.0"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"2.0","value":"1.0"}]}],"title":"Change between baseline and week 3"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.0","upperLimit":"6.0","value":"5.0"},{"groupId":"OG001","lowerLimit":"1.0","upperLimit":"3.0","value":"1.0"}]}],"title":"Change between baseline and week 12"}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"description":"The signs evaluated Will be the following: vaginal mucosa with flattening of folds or thinning, dryness of the mucosa and Fragility of the mucosa.\n\nIt will be scored by the investigator on a numerical scale in accordance with their presence and degree of severity as follows:\n\n0 Absence. The sign is not present.\n\n1. The sign is present and is considered a mild alteration\n2. The sign is present and is considered a moderate alteration\n3. The sign is present and is considered a severe alteration A Total Signs Score will be calculated by summing the intensities of all the three signs of vaginal atrophy in a certain time point, thus ranging between 0 and 9.","dispersionType":"Inter-Quartile Range","groups":[{"description":"Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration","id":"OG000","title":"0.005% Estriol Vaginal Gel"},{"description":"Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration\n\nPlacebo","id":"OG001","title":"Placebo Vaginal Gel"}],"paramType":"MEDIAN","populationDescription":"postmenopausal women","reportingStatus":"POSTED","timeFrame":"week 3 and week 12 vs baseline","title":"Changes in Total Score of Signs of Vaginal Atrophy Between Week 3 and Week 12 to Baseline","type":"SECONDARY","unitOfMeasure":"score on a scale"}