{"analyses":[{"groupDescription":"Change in maturation value from baseline to week 3","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"<0.0001","statisticalMethod":"Wilcoxon (Mann-Whitney)"},{"groupDescription":"Change in maturation value from baseline to week 12","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.006","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-70.04","upperLimit":"-37.8","value":"-62.0"},{"groupId":"OG001","lowerLimit":"-11.6","upperLimit":"2.0","value":"-0.6"}]}],"title":"Change between baseline and week 3"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-55.0","upperLimit":"-5.4","value":"-37.2"},{"groupId":"OG001","lowerLimit":"-36.4","upperLimit":"1.4","value":"-1.0"}]}],"title":"Change between baseline and week 12"}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"description":"Vaginal cytology sample to evaluate the vaginal Maturation Value. For the cytologic evaluation, the number of parabasal, intermediate and superficial cells will be calculated in duplicate on 100 consecutive cells of vaginal cytology. The average of the two percentages obtained for each cell type will be calculated, which will serve to determine the maturation value (MV) based on the following formula:\n\n0.2 x (% parabasal) + 0.6 x (% intermediate) + 1.0 x (% superficial).","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 Vaginal Maturation Value","type":"SECONDARY","unitOfMeasure":"% of cells"}