{"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":">.05","pValueComment":"The reported p-value corresponds to change over time from baseline for 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":"0.15","value":"3.55"},{"groupId":"OG001","spread":"0.14","value":"3.63"},{"groupId":"OG002","spread":"0.45","value":"3.55"}]}],"title":"baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.26","value":"3.87"},{"groupId":"OG001","spread":"0.16","value":"3.90"},{"groupId":"OG002","spread":"0.12","value":"4.03"}]}],"title":"11P DAY 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.15","value":"4.07"},{"groupId":"OG001","spread":"0.15","value":"4.20"},{"groupId":"OG002","spread":"0.44","value":"3.63"}]}],"title":"7A DAY 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.33","value":"3.63"},{"groupId":"OG001","spread":"0.23","value":"3.50"},{"groupId":"OG002","spread":"0.20","value":"3.70"}]}],"title":"3P DAY 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.29","value":"4.13"},{"groupId":"OG001","spread":"0.19","value":"3.52"},{"groupId":"OG002","spread":"0.19","value":"3.63"}]}],"title":"11P DAY 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.26","value":"3.90"},{"groupId":"OG001","spread":"0.19","value":"3.77"},{"groupId":"OG002","spread":"0.39","value":"3.43"}]}],"title":"7A DAY 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.24","value":"3.53"},{"groupId":"OG001","spread":"0.18","value":"3.53"},{"groupId":"OG002","spread":"0.23","value":"3.60"}]}],"title":"3P DAY 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.26","value":"4.03"},{"groupId":"OG001","spread":"0.17","value":"3.58"},{"groupId":"OG002","spread":"0.15","value":"3.70"}]}],"title":"11P DAY 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.22","value":"4.07"},{"groupId":"OG001","spread":"0.13","value":"3.90"},{"groupId":"OG002","spread":"0.40","value":"3.30"}]}],"title":"7A DAY 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.10","value":"3.90"},{"groupId":"OG001","spread":"0.20","value":"3.37"},{"groupId":"OG002","spread":"0.32","value":"3.33"}]}],"title":"3P DAY 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.28","value":"3.67"},{"groupId":"OG001","spread":"0.14","value":"3.48"},{"groupId":"OG002","spread":"0.27","value":"3.63"}]}],"title":"11P DAY 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.19","value":"3.87"},{"groupId":"OG001","spread":"0.14","value":"4.02"},{"groupId":"OG002","spread":"0.30","value":"3.20"}]}],"title":"7A DAY 5"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.29","value":"3.57"},{"groupId":"OG001","spread":"0.20","value":"3.35"},{"groupId":"OG002","spread":"0.21","value":"3.10"}]}],"title":"3P DAY 5"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.23","value":"3.93"},{"groupId":"OG001","spread":"0.20","value":"3.45"},{"groupId":"OG002","spread":"0.32","value":"3.87"}]}],"title":"11P DAY 5"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.06","value":"4.00"},{"groupId":"OG001","spread":"0.10","value":"4.00"},{"groupId":"OG002","spread":"0.35","value":"3.63"}]}],"title":"7A DAY 6"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.03","value":"3.67"},{"groupId":"OG001","spread":"0.14","value":"3.80"},{"groupId":"OG002","spread":"0.19","value":"3.73"}]}],"title":"3P DAY 6"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.18","value":"3.93"},{"groupId":"OG001","spread":"0.10","value":"3.90"},{"groupId":"OG002","spread":"0.09","value":"3.93"}]}],"title":"11P DAY 6"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.10","value":"4.30"},{"groupId":"OG001","spread":"0.12","value":"4.28"},{"groupId":"OG002","spread":"0.38","value":"3.73"}]}],"title":"7A DAY 7"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.09","value":"4.07"},{"groupId":"OG001","spread":"0.20","value":"3.62"},{"groupId":"OG002","spread":"0.20","value":"3.50"}]}],"title":"3P DAY 7"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.26","value":"4.20"},{"groupId":"OG001","spread":"0.19","value":"3.62"},{"groupId":"OG002","spread":"0.30","value":"3.60"}]}],"title":"11P DAY 7"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.15","value":"4.43"},{"groupId":"OG001","spread":"0.10","value":"4.10"},{"groupId":"OG002","spread":"0.23","value":"3.40"}]}],"title":"7A DAY 8"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.38","value":"3.57"},{"groupId":"OG001","spread":"0.26","value":"3.48"},{"groupId":"OG002","spread":"0.09","value":"3.87"}]}],"title":"FOLLOW-UP"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"description":"mg/dl","dispersionType":"Standard Error","groups":[{"description":"PTHrP(1-36) 2 picomoles/kg/hr","id":"OG000","title":"Group 1"},{"description":"PTHrP(1-36) 4 picomoles/kg/hr","id":"OG001","title":"Group 2"},{"description":"PTHrP (1-36) 5 pmol/kg/hr","id":"OG002","title":"Group 3"},{"description":"PTHrP (1-36) 6 picomoles/kg/hr","id":"OG003","title":"Group 4"}],"paramType":"MEAN","reportingStatus":"POSTED","timeFrame":"12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete","title":"Serum Phosphorous","type":"PRIMARY","unitOfMeasure":"mg/dl"}