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Table 4: 
Sample size estimates^a
% Inactive Patients in Placebo Group % Decrease in Mean Lesion Volume of Active Patients Absolute % Increase in Inactive Patients^b
0% 10% 20% 30% 40% 50%
10 0 – – – 435 225 124
10 518 309 204 139 86 65
20 128 101 82 65 47 38
30 56 50 43 35 30 27
40 31 28 24 22 21 19
50 20 19 18 17 16 16
40 0 – – – – – 580
10 470 369 315 251 199 153
20 121 115 94 83 75 66
30 49 44 44 40 37 36
40 25 24 23 24 21 20
50 15 15 15 15 14 15


↵a Number of patients per treatment arm necessary to perform parallel-group-designed trials with a statistical power of 80%, to detect treatment effects ranging from 0% to 50% increase in inactive patients and a 0%–50% reduction in mean enhancing-lesion volume in active patients.


↵b – Indicates percentage increase of patients developing no/zero enhancing lesions during follow-up.