Month	Mean changes from baseline	P (t-test)	p(Signed Wilcoxon)
3	−16.5 (95% CI: −24.5, −8.4)	0.0005	0.0005
6	−28.6 (95% CI: −52.3, −4.9)	0.025	0.016
9	−27.3 (95% CI: −71.7, 17.2)	0.145	0.250
In the MGH topiramate controls: Month Mean changes from baseline
3	−6.0 ± 0.7
6	−12.8 ± 1.0
9	−17.2 ± 1.6

Conclusion: subjects in the thalidomide study had significant decline from baseline in FVC. This decline was significantly greater at three months (p =0.007, calculated using means and standard errors from each trial and a t-distribution approximation using Satterthwaite’s method) than the decline experience by control subjects from the topiramate clinical trial (27).