| Outcome Measures: |
Primary: Change in Hb Concentration From Baseline to Week 16, Change in hemoglobin concentration from baseline to Week 16., 16 weeks | Secondary: Number of Subjects That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 16, Number of subjects that achieve an increase in Hemoglobin concentration of ≥1 g/dL at Week 16, 16 weeks|Number of Subjects That Achieve a Hb Concentration of ≥11 g/dL at Week 16, Number of subjects that achieve a Hemoglobin concentration of ≥11 g/dL at week 16, 16 weeks|Change in Hb Concentration From Baseline to Week 8, Change in Hemoglobin concentration from baseline to Week 8, 8 weeks|Number of Subjects That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 16, Number of subjects that achieve an increase in Hemoglobin concentration of ≥2 g/dL at Week 16, 16 weeks|Changes in Ferritin From Baseline to Week 16, Changes in iron parameter - ferritin - from baseline to week 16, baseline to week 16|Number of Participants With (TEAEs), Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Week 16|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs), Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the double blind phase, Week 16|Changes in TSAT From Baseline to Week 16, Changes in iron parameters - TSAT - from baseline to week 16, baseline to week 16|Changes in Iron Parameter From Baseline to Week 16, Changes in iron parameters - serum iron - from baseline to week 16, from baseline to week 16|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Number of Participants with Treatment-Emergent Adverse Events (TEAEs) during the open label phase, Week 52|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs), Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the open label phase, Week 52
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| Locations: |
Peoria, Arizona, United States|Phoenix, Arizona, United States|Prescott, Arizona, United States|Tucson, Arizona, United States|La Mesa, California, United States|Long Beach, California, United States|Roseville, California, United States|Sacramento, California, United States|Denver, Colorado, United States|Coral Springs, Florida, United States|Edgewater, Florida, United States|Lauderdale Lakes, Florida, United States|Miami, Florida, United States|Macon, Georgia, United States|Shreveport, Louisiana, United States|Pontiac, Michigan, United States|Roseville, Michigan, United States|Las Vegas, Nevada, United States|Asheville, North Carolina, United States|Charlotte, North Carolina, United States|Wilmington, North Carolina, United States|Bethlehem, Pennsylvania, United States|Knoxville, Tennessee, United States|Nashville, Tennessee, United States|El Paso, Texas, United States|San Antonio, Texas, United States|Hampton, Virginia, United States
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