Table 3

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

NRelapses in 2 yearsARR (95% CI)MinMaxIRR (95% CI)P valueIRR (95% CI)*P value*
Placebo27340.63 (0.44 to 0.89)02.50  
Neuroaspis plp102870.13 (0.05 to 0.26)01.05  
 Poisson0.20 (0.09 to 0.45)0.00010.22 (0.09 to 0.51)0.0004
 Negative binomial0.20 (0.09 to 0.46)0.00020.22 (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.