{"analyses":[{"groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalComment":"Stratified Cochran-Mantel-Haenszel (CMH) test (by response status and baseline platelet count),","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG001","value":"70.0"},{"groupId":"OG002","value":"14.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"80"},{"groupId":"OG002","value":"42"}],"units":"Participants"}],"title":"Central Lab"},{"categories":[{"measurements":[{"groupId":"OG000","value":"91.7"},{"groupId":"OG001","value":"92.5"},{"groupId":"OG002","value":"26.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"80"},{"groupId":"OG002","value":"42"}],"units":"Participants"}],"title":"Local Lab"}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"80"},{"groupId":"OG002","value":"42"}],"units":"Participants"}],"description":"Percentage of subjects mobilizing ≥6 × 10\\^6 CD34+ cells/kg with up to 2 apheresis sessions in preparation for autologous hematopoetic cell transplantation (auto-HCT) after treatment with G-CSF + single administration of BL-8040/placebo.\n\nBased on central laboratory data.","groups":[{"description":"Part 1 (lead-in) period. G-CSF given one time daily s.c. for 5-8 days (Days 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed).\n\nFirst apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.","id":"OG000","title":"BL-8040 + G-CSF Part 1"},{"description":"Part 2: randomized, double-blinded, placebo-controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed).\n\nFirst apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.","id":"OG001","title":"BL-8040 + G-CSF Part 2"},{"description":"Part 2: randomized, double-blinded, placebo-controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. Placebo s.c. on Day 4 (and Day 6, if needed).\n\nFirst apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.","id":"OG002","title":"Placebo + G-CSF Part 2"}],"paramType":"NUMBER","populationDescription":"Full Analysis Set (FAS) for Part 1 (Part 1 of the study assessed the mobilization using local lab only), Intention-to-Treat (ITT) for Part 2","reportingStatus":"POSTED","timeFrame":"From first day of study treatment (G-CSF) until day of second apheresis which was planned to occur on Day 6","title":"Percentage of Subjects Mobilizing ≥6 × 10^6 CD34+ Cells/kg With up to 2 Apheresis Sessions","type":"PRIMARY","unitOfMeasure":"Percentage of responders"}