Table 4: Average calculated iron deficit dose in clinical Studies 6 and 7.

Study Patient population Treatment group Calculated mean iron deficit based on the modified Ganzoni formula (mg)Standard deviation Number of patients Total mean

Study 6IDA of various etiologies Cohort 1 (A): 1500 mg IV iron
Cohort 1 (B): oral iron
Cohort 2 (C): 1500 mg IV iron
Cohort 2 (D): IV SoC
1340
1344
1600
1703
356
360
446
482
246
253
252
245
1496 mg

Study 7 (REPAIR-IDA) NDD-CKD1500 mg IV iron
1000 mg IV iron
1355
1349
401
403
1275
1285
1352 mg

Overall mean 1392NC3556

IDA = iron deficiency anemia; NDD-CKD = non-dialysis-dependent chronic kidney disease; SoC = standard of care; NC = not calculated.
Data on file, Luitpold Pharmaceuticals, Inc.