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. Author manuscript; available in PMC: 2010 Mar 29.
Published in final edited form as: J Neurol Neurosurg Psychiatry. 2009 Feb 9;80(11):1218–1223. doi: 10.1136/jnnp.2008.154732

Table 3.

Sample size required to detect the specified reduction in the per cent change estimated from each dataset (table 2) based on a 2 year study with a baseline, year 1 and year 2 scan

Dataset Measurement 33% reduction 50% reduction 90% reduction
RRMS1 GMV 328 147 46
WMV 3859 1712 527
BPV 603 269 84
RRMS2 GMV 1127 503 157
WMV 18944 8425 2605
BPV 724 323 100
RRMS3 GMV 419 187 59
WMV 1414 627 193
BPV 2391 1064 329

Each sample size calculation assumes a 1:1 allocation of patients to treatment and placebo, 80% power and a two sided significance level of 0.05. Sample sizes are totals for both arms.

BPV, brain parenchymal volume; GMV, gray matter volume; RRMS, relapsing–remitting multiple sclerosis; RRMS1, untreated cohort of RRMS patients observed monthly for 9 months14; RRMS2, untreated cohort of RRMS patients observed every 3 months for 1.5 years17; RRMS3, treated cohort of RRMS patients observed monthly for 9 months14; WMV, white matter volume.