{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"}],"units":"Participants"}],"title":"First Stage"},{"categories":[{"measurements":[{"groupId":"OG000","value":"44"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"47"}],"units":"Participants"}],"title":"Second Stage (Overall)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"47"}],"units":"Participants"}],"description":"Patients completing at least 19 out of 24 ALTENS therapy sessions were categorized as compliant. Fleming's two-stage was used, assuming a successful target compliance rate of 80%, statistical power of 0.87, and a type I error rate of 0.13. If fewer than 9 of the first 13 patients were compliant, then treatment delivery will be deemed not feasible. If there were between 9-12 compliant patients, the second stage analysis would be required to determine feasibility of treatment delivery. If all 13 patients are compliant, treatment delivery will immediately be deemed feasible. The second stage analysis required at least 31 compliant out of 39 overall patients for the treatment delivery to be deemed feasible.","groups":[{"description":"Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit","id":"OG000","title":"ALTENS: Phase II"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Eligible patients starting protocol treatment","reportingStatus":"POSTED","timeFrame":"Randomization to 12 weeks","title":"Phase II: Treatment Compliance (Number of Compliant Patients)","type":"PRIMARY","unitOfMeasure":"Participants"}