Figure 1. CONSORT flow chart. Multiple individuals were discontinued due to a high hemoglobin (Hb) level response (these were not participants who: [1] met criteria for early termination on account of adverse events, [2] withdrew themselves, or [3] withdrew consent). Based on the large number of discontinued individuals, the primary short-term efficacy end point included both individuals who received all 28 days of dosing and those who discontinued between days 22 and 28. Individuals who discontinued prior to day 22, who by definition had an increase > 1.0 g/dL, were not included in the analysis. Had these individuals continued dosing, they would have contributed to a positive outcome for the primary end point analysis. Abbreviations: CKD-3/4/5, chronic kidney disease stages 3, 4, or 5; CKD-5D, dialysis-dependent chronic kidney disease stage 5.