Table 3.

Primary end point as determined by clinical results for the intention-to-treat (ITT) population

	N	Relapses in 2 years	ARR (95% CI)	Min	Max		IRR (95% CI)	P value	IRR (95% CI)*	P value*
Placebo	27	34	0.63 (0.44 to 0.89)	0	2.50
Neuroaspis plp10	28	7	0.13 (0.05 to 0.26)	0	1.05
						Poisson	0.20 (0.09 to 0.45)	0.0001	0.22 (0.09 to 0.51)	0.0004
						Negative binomial	0.20 (0.09 to 0.46)	0.0002	0.22 (0.09 to 0.51)	0.0004

*Adjusted for: age, sex, years of diagnosis, baseline EDSS, relapses during normalisation.

ARR, annualised relapse rate; EDSS, Expanded Disability Status Scale; IRR, incidence rate ratio.