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) | Median (IQR) | Median (IQR) | Median (95% CI) | |||

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) (mm^{3}) | 1753.50 (553.00–4974.50) | 185.00 (0.00–1450.00) | −829.0 (−2188 to −184) | 0.0481 | ||||

Volume of new enhancing lesions (mm^{3}) | 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.