{"analyses":[{"ciNumSides":"TWO_SIDED","groupIds":["OG000","OG001","OG002"],"nonInferiorityComment":"The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","pValue":"<.008","pValueComment":"The reported p-value corresponds to the % increase compared to baseline in all Arms/groups on Days 2-8.","statisticalComment":"The level of statistical significance was set at .05 (two-tailed)","statisticalMethod":"Mixed Models Analysis","testedNonInferiority":true},{"ciNumSides":"TWO_SIDED","groupIds":["OG000","OG001","OG002"],"nonInferiorityComment":"The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","pValue":">0.05","pValueComment":"The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups","statisticalComment":"The level of statistical significance was set at .05 (two-tailed)","statisticalMethod":"Mixed Models Analysis","testedNonInferiority":true}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.00","value":"0.00"},{"groupId":"OG001","spread":"0.00","value":"0.00"},{"groupId":"OG002","spread":"0.00","value":"0.00"}]}],"title":"baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.41","value":"32.86"},{"groupId":"OG001","spread":"18.79","value":"87.75"},{"groupId":"OG002","spread":"10.64","value":"54.21"}]}],"title":"Day 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.19","value":"26.73"},{"groupId":"OG001","spread":"28.94","value":"91.53"},{"groupId":"OG002","spread":"19.99","value":"88.51"}]}],"title":"Day 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.26","value":"28.32"},{"groupId":"OG001","spread":"32.25","value":"90.86"},{"groupId":"OG002","spread":"20.22","value":"89.57"}]}],"title":"Day 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.06","value":"41.29"},{"groupId":"OG001","spread":"20.62","value":"82.36"},{"groupId":"OG002","spread":"13.85","value":"116.58"}]}],"title":"Day 5"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"12.63","value":"11.41"},{"groupId":"OG001","spread":"28.62","value":"123.08"},{"groupId":"OG002","spread":"48.26","value":"150.82"}]}],"title":"Day 6"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.44","value":"35.04"},{"groupId":"OG001","spread":"41.54","value":"161.55"},{"groupId":"OG002","spread":"50.08","value":"176.42"}]}],"title":"Day 7"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"30.43","value":"65.77"},{"groupId":"OG001","spread":"59.26","value":"214.90"},{"groupId":"OG002","spread":"34.29","value":"108.69"}]}],"title":"Day 8"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.97","value":"-14.95"},{"groupId":"OG001","spread":"6.68","value":"-3.33"},{"groupId":"OG002","spread":"7.19","value":"-9.02"}]}],"title":"follow-up"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"description":"% change from baseline","dispersionType":"Standard Error","groups":[{"description":"PTHrP(1-36) 2 picomoles/kg/hr for one week.","id":"OG000","title":"Group 1"},{"description":"PTHrP(1-36) 4 picomoles/kg/hr for one week.","id":"OG001","title":"Group 2"},{"description":"PTHrP(1-36) 5 picomoles/kg/hr for one week.","id":"OG002","title":"Group 3"},{"description":"PTHrP(1-36) 6 picomoles/kg/hr for one week.","id":"OG003","title":"Group 4"}],"paramType":"MEAN","reportingStatus":"POSTED","timeFrame":"Baseline, Daily, and 1 week follow-up","title":"Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)","type":"SECONDARY","unitOfMeasure":"% change"}