{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.99","spread":"3.8","upperLimit":"7.38","value":"4.0"},{"groupId":"OG001","lowerLimit":"-0.16","spread":"2.8","upperLimit":"1.84","value":"3.0"}]}],"title":"Mean IgM at baseline (mcg/mL)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.07","value":"2.91"},{"groupId":"OG001","spread":"0.83","value":"0.57"}]}],"title":"Mean IgM change from baseline (mcg/mL)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"5"}],"units":"Participants"}],"description":"Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Serum immunoglobulin IgM antibodies were determined by enzyme-linked immunosorbent assay (ELISA). Baseline is defined as the IgM concentration before the KLH vaccination. Change from baseline was calculated as the IgM value postvaccination minus the IgM value at prevaccination.","dispersionType":"Standard Deviation","groups":[{"description":"Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.","id":"OG000","title":"Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month"},{"description":"Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.","id":"OG001","title":"Placebo"}],"paramType":"MEAN","populationDescription":"Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for IgM. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.","reportingStatus":"POSTED","timeFrame":"Month 6 prevaccination (baseline) and Month 7 postvaccination","title":"Mean Change From Baseline in IgM Response (Mcg/mL) Before Keyhole Limpet Hemocyanin (KLH) Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo","type":"PRIMARY","unitOfMeasure":"mcg/mL"}