Table 1.

Baseline characteristics of patients (ITT).

	High dose	Low dose	p-value
Total (n) [within group (%)]	28 [53]	25 [47]	>0.99a
Disease course (n)
RRMS	26	25	0.49a
CIS	2	0
Female [within group (%)]	20 [71]	17 [68]	>0.99a
Mean age at screening (years) [SE]	41 [2.1]	45 [1.8]	0.26b
Mean disease duration onset to screening (months) [SE]	97 [14.4]	125 [16.8]	0.24b
Mean BMI at screening [SE]	27.2 [1.3]	25.5 [0.9]	0.61b
Median EDSS [range]	2.0 [5.0]	2.5 [6.0]	0.18b
Mean 25OH vitamin D serum level (ng/ml) [SE]	18.8 [1.9]	17.8 [1.7]	0.9b
Mean T2w lesion count (n) [SE]	52.6 [6.7]	76.1 [10.7]	0.08b
Mean T2w lesion volume (ml) [SE]	4.6 [0.9]	10.4 [1.9]	0.01b
Mean brain parenchymal fraction (ml) [SE]	1163.1 [25.8]	1121.3 [18.1]	0.4b
Mean thalamus volume (ml) [SE]	15.5 [0.4]	14.4 [0.4]	0.05b
Total gd+ lesions (n)	4	2	>0.99b

BMI: body mass index; CIS: clinically isolated syndrome; EDSS: Expanded Disability Status Scale; gd+: gadolinium enhancing lesions; ITT: intention to treat; MSFC: Multiple Sclerosis Functional Composite; n: number; RRMS: relapsing remitting MS; SE: standard error.

^aexact Chi-Square tests; ^bexact Mann–Whitney U test