Table 2

Primary and secondary MRI outcomes

Intention-to-treat cohort (n=38)					Per-protocol cohort (n=28)
	Baseline (months −3 to 0) n=38	Treatment (months 5–8) n=33*	Difference n=33*	P value (BOCF) n=38	Baseline (months −3 to 0) n=28	Treatment (months 5–8) n=28	Difference n=28	P value n=28
	Median (IQR)	Median (IQR)	Median (95% CI)	P value (BOCF) n=38	Median (IQR)	Median (IQR)	Median (95% CI)	P value n=28
Number of new enhancing lesions	1.00 (0.75–3.00)	0.25 (0.00–0.75)	−0.75 (−1.083 to −0.50)	<0.0001	0.88 (0.63–2.63)	0.25 (0.00–0.75)	−0.625 (−1.25 to −0.50)	<0.0001
Number of total enhancing lesions	1.25 (0.75–3.50)	0.50 (0.00–1.00)	−0.75 (−1.083 to −0.50)	<0.0001	1.00 (0.75–3.38)	0.50 (0.00–1.13)	−0.625 (−1.25 to −0.50)	<0.0001
Number of new T2 lesions	8.50 (4.75–14.50)	0.25 (0.00–0.75)	−6.00 (−10.25 to −4.00)	<0.0001	7.50 (4.88–12.88)	0.25 (0.00–0.75)	−6.50 (−10.25 to −4.00)	<0.0001
Volume of total enhancing lesions (new and persisting) (mm³)					1753.50 (553.00–4974.50)	185.00 (0.00–1450.00)	−829.0 (−2188 to −184)	0.0481
Volume of new enhancing lesions (mm³)					1087.00 (407.50–3343.00)	92.50 (0.00–725.00)	−611.0 (−1094 to −92)	0.0243
Change in volume of T2 lesions					264.50 (−1048.50 to 1304.00)	301.50 (−123.50 to 1045.00)	−34.5 (−582 to 435)	0.9118
Parenchymal brain volume change (%)					−0.12 (−0.36 to 0.13)	0.11 (−0.25 to 0.30)	0.21 (−0.06 to 0.60)	0.0081

P values are reported as results of Wilcoxon signed-rank test.
*Missing data changes for n=10 patients in outcomes from baseline to follow-up were imputed as 0 (‘intention-to-treat analysis’); for n=5 of these patients at least one MRI result was available during the treatment phase.
BOCF, baseline observation carried forward.