{"analyses":[{"groupDescription":"The final on treatment values were included in the analysis.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.125","statisticalComment":"The statistical method used for a 1-way ANOVA between treatment groups.","statisticalMethod":"ANOVA","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"47.0863","value":"67.524"},{"groupId":"OG001","spread":"206.1733","value":"173.712"}]}],"title":"Baseline TREC per 100,000 CD4+ cells"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"920.790","value":"522.321"},{"groupId":"OG001","spread":"235.561","value":"-63.950"}]}],"title":"Mean change in TREC from baseline to final visit"}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"7"}],"units":"Participants"}],"description":"CD4+ cells are a type of T cell. T cells are produced in the thymus and thymic function can be determined by TREC. By counting the number of TRECs present (only 1 copy per cell) within a population of CD4 cells, an assessment of T cell recovery and immune response is obtained. Mayo Medical Clinic. http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/87959. Accessed 17 MARCH 2010\n\nThe change from baseline is defined as posttransplant TREC/100,000 CD4+ cells minus pretransplant TREC /100,000 CD4+ cells.","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":"Nine subjects from the LAD-treated arm and 7 subjects from the placebo-treated arm were assessed for TREC per 100,000 CD4+ cells. 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":"Pretransplant and posttransplant (Month 12)","title":"Mean Change From Baseline in T Cell Excision Circles (TREC) Per 100,000 CD4+ Cells to Final Visit in Patients Treated With LAD (11.25 mg) or Placebo After Transplant","type":"SECONDARY","unitOfMeasure":"TREC /100,000 CD4+ cells"}