Demographic, clinical and MRI baseline characteristics for the total randomised population (intention-to-treat (ITT) population) by treatment arm
| Placebo | Neuroaspis plp10 | ||||||||
| N | Mean±SD/median (IQR)/ N (%) | Min | Max | N | Mean±SD/median (IQR)/ N (%) | Min | Max | P value | |
| Age | 27 | 37.48±6.73 | 26 | 55 | 28 | 37.71±8.28 | 24 | 55 | 0.946 |
| Sex (female) | 27 | 16 (59.3) | – | – | 28 | 17 (60.7) | – | – | 0.912 |
| Years of diagnosis | 27 | 10.67±7.02 | 2 | 28 | 28 | 9.71±5.68 | 2 | 26 | 0.826 |
| Weight (kg) | 27 | 70.67±17.95 | 48 | 110 | 28 | 69.75±13.26 | 46 | 100 | 0.893 |
| Height (cm) | 27 | 169.11±10.30 | 155 | 206 | 28 | 168.68±8.63 | 155 | 183 | 0.986 |
| EDSS Score visit 1 (normalisation phase) | 27 | 2.5 (2–3.5) | 1 | 5 | 28 | 2 (1.5–2.75) | 1 | 4 | 0.111 |
| EDSS Score visit 2 (baseline) | 27 | 3 (2–3.5) | 1 | 5 | 27 | 2 (1.5–3) | 1 | 4.5 | 0.100 |
| Annualised relapse rate (estimated from normalisation phase) | 27 | 0.30±0.74 | 0 | 2.23 | 28 | 0.4±1.05 | 0 | 3.8 | 1.000 |
| Relapses at normalisation phase | 27 | 28 | |||||||
| 0 | 23 (85.19) | – | – | 24 (85.71) | – | – | |||
| 1 | 4 (14.81) | – | – | 3 (10.71) | – | – | 1.000* | ||
| 2 | 0 (0) | – | – | 1 (3.57) | – | – | |||
| Total number of T1-enhancing lesions | 26 | 0.23±0.51 | 0 | 2 | 28 | 0.36±0.73 | 0 | 3 | 0.691 |
| T1-enhancing lesion volume (mm3) | 26 | 29.77±66.36 | 0 | 257 | 28 | 50.25±129.66 | 0 | 589 | 0.762 |
| T2-hyperintense lesion volume (mm3) | 27 | 6623.48±5692.45 | 185 | 24 763 | 28 | 5049.93±3833.54 | 488 | 14 810 | 0.429 |
Percentages may not sum to 100 because of rounding.
*Fisher’s exact test.
EDSS, Expanded Disability Status Scale (range of scores, 0–10, with higher scores indicating more severe disease).;