Parameter	On‐demand FVIII treatment before study (OD)		Prophylactic FVIII treatment before study (PPx)
	FVIII trough level 1–3%	FVIII trough level 8–12%	Average ABR <5 in 12 months before enrollment		Average ABR ≥5 in 12 months before enrollment
			FVIII trough level 1–3%	FVIII trough level 8–12%	FVIII trough level 1–3%	FVIII trough level 8–12%
Patients, n	13	13	19	14	20	16
Patients with total ABR = 0, %	46.2 (19.2–74.9)	84.6 (54.6–98.1)	42.1 (20.3–66.5)	71.4 (41.9–91.6)	35.0 (15.4–59.2)	50.0 (24.7–75.3)
Patients with spontaneous ABR = 0, %	69.2 (38.6–90.9)	92.3 (64.0–99.8)	57.9 (33.5–79.7)	85.7 (57.2–98.2)	55.0 (31.5–76.9)	68.8 (41.3–89.0)
Patients with spontaneous joint ABR = 0, %	69.2 (38.6–90.9)	100.0 (NA)	63.2 (38.4–83.7)	92.9 (66.1–99.8)	65.0 (40.8–84.6)	81.3 (54.4–96.0)
Patients with injury‐related ABR = 0, %	69.2 (38.6–90.9)	92.3 (64.0–99.8)	73.7 (48.8–90.9)	85.7 (57.2–98.2)	65.0 (40.8–84.6)	56.3 (29.9–80.2)

ABR, annualized bleeding rate; CI, confidence interval; FVIII, factor VIII; NA, not applicable; PPAS, per‐protocol analysis set.

*Patients in the PPAS completed the second 6 months of prophylaxis with no significant protocol deviations.