{"analyses":[{"groupDescription":"Changes in dryness of the mucosa between baseline and week 3","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.13","statisticalMethod":"Wilcoxon (Mann-Whitney)"},{"groupDescription":"Changes in dryness of the mucosa between baseline and week 12","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"<0.01","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"2.0","value":"1.0"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"1.0","value":"0.0"}]}],"title":"Changes from baseline to week 3"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.0","upperLimit":"2.0","value":"1.5"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"1.0","value":"0.5"}]}],"title":"Changes from baseline to week 12"}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"description":"It 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","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":"from baseline to week 3 and 12","title":"Changes in Fragility of the Mucosa [Time Frame: Week 3 and Week 12 vs Baseline]","type":"SECONDARY","unitOfMeasure":"score on a scale"}