Table 4

Section A reports the 2-year primary end points of the ARR for the all-time on-study population by treatment arm and per cent difference from the placebo and section B reports the comparison of the 24-month pretreatment ARR with the 24-month on-treatment ARR of the all-time on-study population excluding patients on natalizumab and the comparison of the ARR during the 24-month period on-treatment (primary end point) for each treatment group compared with the placebo

Section A Characteristics	Group A (N=10)		Group B*(N=10)		Group C (N=9)		Placebo (N=12)
End point	X	Y	X	Y	X	Y	X	Y
Total number of relapses	22	17	27	8	16	13	20	25
Annual relapse rate (ARR)	1.10	0.85	1.35	0.40	0.88	0.72	0.83	1.04
Percentage of reduction compared with placebo (primary end point)†		−18		−62		−30		N/A
p Value against placebo		0.468		0.024		0.578
ARR change % (Y to X)†		−23		−70		−18		+25
p Value against baseline		0.425		0.003		0.578		0.500

Section B Excluding patients on natalizumab	Group A (N=9)		Group B* (N=10)		Group C (N=9)		Placebo (N=10)

End point	X	Y	X	Y	X	Y	X	Y
Total number of relapses	16	15	27	8	16	13	13	19
ARR	0.88	0.83	1.35	0.40	0.88	0.72	0.65	0.95
Percentage reduction compared with placebo (primary end point)†		−13		−58		−24		N/A
p Value against placebo		0.493		0.016		0.412
ARR change % (Y to X)†		−6		−70		−18		+46
p Value against baseline		0.857		0.003		0.578		0.354

Section A: During the 24-month period on-treatment, the ARR of group A was 0.85, with an 18% decrease compared with placebo (p=0.468); that of the PLP10 group was 0.40, with a 62% decrease (p=0.024); and that of group C was 0.72, with a 30% decrease (p=0.578). This section also reports the comparison of the 24-month pretreatment ARR (baseline ARR) with the 24-month on-treatment ARR of the all-time on-study population, including patients on natalizumab.
X: total number of relapses for the 24 months pretreatment (baseline).
Y: total number of relapses for the 24 months on-treatment.
*PLP10 group.
†Unadjusted estimate.