{"analyses":[{"groupDescription":"An effect size of 0.50 was chosen for sample size calculation. On the basis of a 2-sided t test with alpha= 0.05 and 1 interim analysis, 130 patients were required for 80% statistical power. Adjustment by 10% for loss to follow-up and retrospective ineligibility of recruited study participants yielded a sample size of 144 patients. Actual power given only 96 patients was 68.6%","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.45","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1.06","upperLimit":"0","value":"-0.27"},{"groupId":"OG001","lowerLimit":"-0.87","upperLimit":"-0.2","value":"-0.53"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"53"}],"units":"Participants"}],"description":"Xerostomia burden is measured by the University of Michigan Xerostomia Related Quality of Life Scale (XeQOLS). The XeQOLS is a validated patient-reported 15-item assessment scale with 4 domains: physical functioning,pain/discomfort, personal/psychologic functioning, and social functioning.The score is the average of all responses of all domains and can range from 0 to 4, with higher scores indicating increased xerostomia burden. Change in xerostomia burden is calculated by subtracting the baseline score from the 9-month score such that a negative change indicates an improvement of the xerostomia burden.","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 randomized patients with both baseline and 9 month XeQOLS scores","reportingStatus":"POSTED","timeFrame":"Baseline (randomization) and 9 months","title":"Phase III: Change From Baseline in Overall Xerostomia Burden at 9 Months","type":"PRIMARY","unitOfMeasure":"units on a scale"}