{"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":"<.0001","pValueComment":"the reported p-value corresponds to % decrease compared to baseline at Days 2-8 in all Arms/groups","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":"0.01","pValueComment":"the reported p-value corresponds to % change from baseline at the follow-up visit 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":"4.95","value":"-1.05"},{"groupId":"OG001","spread":"5.93","value":"-17.49"},{"groupId":"OG002","spread":"6.05","value":"-23.88"}]}],"title":"Day 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.78","value":"-6.83"},{"groupId":"OG001","spread":"7.10","value":"-30.44"},{"groupId":"OG002","spread":"6.56","value":"-37.77"}]}],"title":"Day 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.57","value":"-12.16"},{"groupId":"OG001","spread":"9.55","value":"-25.66"},{"groupId":"OG002","spread":"4.46","value":"-39.44"}]}],"title":"Day 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.27","value":"-5.63"},{"groupId":"OG001","spread":"8.01","value":"-21.27"},{"groupId":"OG002","spread":"3.07","value":"-45.04"}]}],"title":"Day 5"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"5.07","value":"-8.42"},{"groupId":"OG001","spread":"7.50","value":"-31.71"},{"groupId":"OG002","spread":"1.75","value":"-39.55"}]}],"title":"Day 6"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.17","value":"-12.59"},{"groupId":"OG001","spread":"8.87","value":"-30.98"},{"groupId":"OG002","spread":"2.78","value":"-39.88"}]}],"title":"Day 7"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"5.03","value":"-16.03"},{"groupId":"OG001","spread":"9.64","value":"-36.60"},{"groupId":"OG002","spread":"3.40","value":"-38.53"}]}],"title":"Day 8"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.29","value":"-7.12"},{"groupId":"OG001","spread":"9.58","value":"0.60"},{"groupId":"OG002","spread":"17.34","value":"46.67"}]}],"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":"Amino-terminal Peptides of Procollagen 1 (P1NP)","type":"SECONDARY","unitOfMeasure":"% change"}