{"analyses":[{"groupDescription":"Changes in vaginal dryness from baseline to week 3","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.14","statisticalMethod":"Wilcoxon (Mann-Whitney)"},{"groupDescription":"Changes in vaginal dryness from baseline to week 12","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"<0.01","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.0","upperLimit":"2.0","value":"1.0"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"1.0","value":"1.0"}]}],"title":"Change between baseline and week 3"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.0","upperLimit":"2.0","value":"2.0"},{"groupId":"OG001","lowerLimit":"1.0","upperLimit":"1.0","value":"1.0"}]}],"title":"Change between baseline and week 12"}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"description":"Change in vaginal dryness puntuation score from baseline to w3 and w12\n\nEach symptom will be scored in a numeric scale from 0 to 3, as shown below:\n\n0 Absence. The symptom is not present\n\n1. The symptom is of mild intensity, without interfering in the patient's activity\n2. The symptom is of moderate intensity, causing obvious discomfort to the patient\n3. The symptom is stated as very irritating and severe in intensity","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\n\nestriol","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 Dryness","type":"SECONDARY","unitOfMeasure":"units on a scale"}