Table 1.

Baseline demographic and clinical metrics, along with MRI outcome measures after run-in.

Patient characteristic	FR (n = 29)	CW (n = 27)	P-value
AGE, YEARS
Mean ± SD	37.07 ± 7.25	35.70 ± 8.03	0.507a
Median (IQR)	39 (33.50–40.50)	37 (30–40)
SEX
M/F	12/17	10/17	0.789b
DISEASE DURATION, MONTHS
Mean ± SD	48.45 ± 61.43	82.89 ± 91.54	0.130c
Median (IQR)	15 (6–65)	48 (10–156)
RELAPSE NUMBERd
Mean ± SD	2.25 ± 1.29	2.38 ± 1.33	0.714a
Median (IQR)	2 (1–3)	2.31 (1–3)
EDSS SCORE
Mean ± SD	1.49 ± 1.28	1.25 ± 0.73	0.941c
Median (IQR)	1.5 (1–1.75)	1 (1–1.5)
CUMULATIVE NUMBER OF GD-ENHANCING LESIONS AT MRI
Mean ± SD	5.66 ± 11.58	2.81 ± 4.05	0.486c
Median (IQR)	1 (0–3)	0 (0–4)
CUMULATIVE NUMBER OF NEW AND ENLARGING T2-WEIGHTED LESIONS AT MRI
Mean ± SD	2.93 ± 5.61	1.74 ± 3.94	0.483c
Median (IQR)	1 (0–2)	0 (0–2)
NUMBER OF PATIENTS WITH AT LEAST AN ACTIVE SCAN DURING RUN-IN
N	20	18	0.854b
	(n = 24)e	(n = 25)e
BLACK HOLES NUMBER f
Mean ± SD	2.58 ± 4.46	1.20 ± 1.80	0.879c
Median (IQR)	0 (0–4)	0 (0–2)
Range	0–18	0–7
BLACK HOLES–OVERALL VOLUMEf (cm3)
Mean ± SD	222.06 ± 442.83	586.92 ± 1523.14	0.831c
Median (IQR)	0 (0–208.62)	0 (0–371.93)
Range	0–1659.39	0–6673.33

^at-test for continuous variables.

^bChi-square test for categorical variables.

^cNon-parametric Wilcoxon rank-sum test (for variables with non-normal distribution).

^dBefore study entry.

^eThe baseline demographic and clinical characteristics of this subgroup were not different from those of the 7 patients lost for this analysis.

^fAfter run-in.