Table 4. Secondary endpoints – Hematologic parameters (% [n] or mean [SD]) (ITT).

	FCM (N = 144)		Placebo (N = 146)
	Baseline	Day 56	Baseline	Day 56	Difference [95% CI] FCM–placebo on Day 56, P-value
Hb ≥120 g/L ‡ , §	86.8 (125)	100 (144)	85.6 (125)	80.8 (118)	19.2 [12.8, 25.6], P<0.001
Serum ferritin ≥50 µg/L ‡ , §	0.7 (1)	99.3 (143)	1.4 (2)	2.1 (3)	97.3 [94.6, 99.9], P<0.001
TSAT ≥20% ‡ , §	9.9 (14)	81.3 (117)	13.8 (20)	32.9 (48)	48.4 [38.4, 58.3], P<0.001
MCV (fl) ‡ , §	87.3 (4.5)	89.6 (3.9)	87.4 (4.4)	87.2 (4.8)	2.41 [1.39, 3.42], P<0.0001

^‡A positive value of the difference FCM–placebo is in favor of FCM;

^§Mean Hb levels at Day 56 were 134±7.7 g/L (FCM) vs. 127±10.1 g/L (placebo), median serum ferritin levels at Day 56 were 169 µg/L (FCM) vs. 16 µg/L (placebo) and median TSAT was 27% (FCM) vs. 15% (placebo).

Hb hemoglobin; TSAT transferrin saturation; MCV mean corpuscular volume.