{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.97","pValueComment":"4-month score; two-sided test, significance level 0.05","statisticalMethod":"Wilcoxon (Mann-Whitney)"},{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.83","pValueComment":"6-months; two-sided test, significance level 0.05","statisticalMethod":"Wilcoxon (Mann-Whitney)"},{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.28","pValueComment":"9-months; two-sided test, significance level 0.05","statisticalMethod":"Wilcoxon (Mann-Whitney)"},{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.89","pValueComment":"15-months; two-sided test, significance level 0.05","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.12","upperLimit":"1.4","value":"0.03"},{"groupId":"OG001","lowerLimit":"-0.2","upperLimit":"0.9","value":"0.2"}]}],"title":"4 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.27","upperLimit":"1.33","value":"0.2"},{"groupId":"OG001","lowerLimit":"-0.3","upperLimit":"1.07","value":"0.40"}]}],"title":"6 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"1.9","value":"0.99"},{"groupId":"OG001","lowerLimit":"-0.17","upperLimit":"1.44","value":"0.60"}]}],"title":"9 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.3","upperLimit":"1.7","value":"0.3"},{"groupId":"OG001","lowerLimit":"-0.13","upperLimit":"2","value":"0.20"}]}],"title":"15 months"}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"73"}],"units":"Participants"}],"description":"Stimulated (citric acid primed) whole salivary production (WSP) was measured by expectoration weight, with one gram of saliva produced considered as one ml of saliva. WSP is expressed in ml/min calculated by dividing the measured weight or volume of WSP by five. Procedure: Patients refrain from eating, drinking, and smoking at least two hours prior to each measurement. Stimulation is elicited by asking patients to rinse 5 ml of 2% citric acid solution in the mouth for 15 seconds and then completely expectorating the citric acid. For each measurement, patients are asked to expectorate continuously into a pre-weighed dry plastic container over a 5-minute period without swallowing. The collected saliva with the plastic container will be weighed (total weight) immediately after each collection. The total weight minus the weight of the container is the weight or volume of whole saliva collected.","dispersionType":"Inter-Quartile Range","groups":[{"description":"5mg pilocarpine by mouth 3 times a day for 12 weeks","id":"OG000","title":"Pilocarpine: Phase III"},{"description":"Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit","id":"OG001","title":"ALTENS: Phase III"}],"paramType":"MEDIAN","populationDescription":"Eligible patients with both baseline and respective follow-up (4,6, 9,15 months) WSP measurements.","reportingStatus":"POSTED","timeFrame":"Baseline, 4, 6, 9 and 15 months from randomization","title":"Change From Baseline in Stimulated Whole Salivary Production (WSP) at 4, 6, 9 and 15 Months (Phase III)","type":"SECONDARY","unitOfMeasure":"ml/min"}