{"analyses":[{"ciNumSides":"TWO_SIDED","groupIds":["OG001"],"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":"0.001","pValueComment":"the reported p-value correspond to the decrease compared to baseline over time in the PTHrP 4 pmol group.","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":".01","pValueComment":"the reported p=value corresponds to % change compared to 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":"8.60","value":"-12.53"},{"groupId":"OG001","spread":"4.10","value":"-1.17"},{"groupId":"OG002","spread":"7.01","value":"24.54"}]}],"title":"Day 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"4.84","value":"-6.35"},{"groupId":"OG001","spread":"3.07","value":"-1.44"},{"groupId":"OG002","spread":"6.53","value":"34.77"}]}],"title":"Day 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.58","value":"-5.82"},{"groupId":"OG001","spread":"4.65","value":"-3.79"},{"groupId":"OG002","spread":"8.23","value":"19.49"}]}],"title":"Day 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.33","value":"-0.33"},{"groupId":"OG001","spread":"4.73","value":"-9.64"},{"groupId":"OG002","spread":"9.76","value":"13.61"}]}],"title":"Day 5"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.32","value":"-8.16"},{"groupId":"OG001","spread":"4.04","value":"-10.88"},{"groupId":"OG002","spread":"8.94","value":"9.02"}]}],"title":"Day 6"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"10.38","value":"-11.91"},{"groupId":"OG001","spread":"2.58","value":"-16.78"},{"groupId":"OG002","spread":"4.01","value":"9.86"}]}],"title":"Day 7"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"8.66","value":"-7.80"},{"groupId":"OG001","spread":"3.72","value":"-14.01"},{"groupId":"OG002","spread":"11.63","value":"15.27"}]}],"title":"Day 8"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.70","value":"-1.25"},{"groupId":"OG001","spread":"3.81","value":"6.16"},{"groupId":"OG002","spread":"2.22","value":"18.23"}]}],"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":"Bone Specific Alkaline Phosphatase (BSAP)","type":"SECONDARY","unitOfMeasure":"% change"}