Table 1 Change From Baseline in the Monthly Average Number of Migraine Days During 12 Weeks of Double-blind Treatment (Primary Efficacy) in Individual Countries and Overall^a

All (n = 838)

(n = 279)

(n = 276)

(n = 283)

Change from baseline (SE)

− 0.6 (0.34)

− 3.7 (0.34)

− 4.1 (0.34)

Difference from placebo (95% CI)

− 3.1 (− 3.84, − 2.42)

− 3.5 (− 4.19, − 2.78)

P value

< 0.001

< 0.001

Czech Republic (n = 188)

(n = 60)

(n = 65)

(n = 63)

Change from baseline (SE)

− 1.4 (0.66)

− 3.3 (0.62)

− 4.4 (0.63)

Difference from placebo (95% CI)

− 1.9 (− 3.25, − 0.47)

− 3.0 (− 4.39, − 1.59)

P value

0.009

< 0.001

USA (n = 119)

(n = 39)

(n = 39)

(n = 41)

Change from baseline (SE)

− 0.2 (0.86)

− 3.9 (0.88)

− 4.4 (0.86)

Difference from placebo (95% CI)

− 3.7 (− 5.77, − 1.58)

− 4.2 (− 6.23, − 2.13)

P value

< 0.001

< 0.001

Finland (n = 85)

(n = 27)

(n = 29)

(n = 29)

Change from baseline (SE)

− 0.5 (1.14)

− 3.5 (1.04)

− 4.3 (1.14)

Difference from placebo (95% CI)

− 3.0 (− 5.32, − 0.63)

− 3.9 (− 6.27, − 1.44)

P value

0.01

0.002

Belgium (n = 50)

(n = 15)

(n = 18)

(n = 17)

Change from baseline (SE)

− 0.4 (1.13)

− 2.8 (1.08)

− 2.8 (1.13)

Difference from placebo (95% CI)

− 2.4 (− 5.41, 0.63)

− 2.4 (− 5.44, 0.67)

P value

0.12

0.12

Denmark (n = 34)

(n = 12)

(n = 11)

(n = 11)

Change from baseline (SE)

0 (2.00)

− 4.0 (2.27)

− 3.4 (2.07)

Difference from placebo (95% CI)

− 4.0 (− 7.77, − 0.20)

− 3.4 (− 7.38, 0.53)

P value

0.04

0.09

France (n = 35)

(n = 13)

(n = 10)

(n = 12)

Change from baseline (SE)

− 3.1 (1.78)

− 6.0 (1.84)

− 8.4 (1.97)

Difference from placebo (95% CI)

− 2.8 (−7.38, 1.76)

− 5.3 (−9.86, −0.64)

P value

0.22

0.03

Germany (n = 74)

(n = 25)

(n = 24)

(n = 25)

Change from baseline (SE)

− 0.5 (1.17)

− 4.7 (1.25)

− 5.2 (1.16)

Difference from placebo (95% CI)

− 4.2 (− 6.76, − 1.61)

− 4.7 (− 7.17, − 2.14)

P value

0.002

< 0.001

The Netherlands (n = 23)

(n = 7)

(n = 8)

(n = 8)

Change from baseline (SE)

− 0.1 (1.66)

− 5.6 (1.41)

− 4.6 (1.29)

Difference from placebo (95% CI)

− 5.6 (− 9.52, − 1.60)

− 4.5 (− 8.65, − 0.44)

P value

0.009

0.03

Poland (n = 66)

(n = 23)

(n = 19)

(n = 24)

Change from baseline (SE)

− 2.5 (1.13)

− 5.7 (1.35)

− 5.7 (1.12)

Difference from placebo (95% CI)

− 3.1 (− 6.13, − 0.16)

− 3.2 (− 5.77, − 0.59)

P value

0.04

0.02

Spain (n = 78)

(n = 30)

(n = 25)

(n = 23)

Change from baseline (SE)

− 0.5 (1.16)

− 3.3 (1.28)

− 2.0 (1.61)

Difference from placebo (95% CI)

− 2.9 (− 5.61, − 0.14)

− 1.5 (− 4.53, 1.51)

P value

0.04

0.32

Sweden (n = 37)

(n = 12)

(n = 12)

(n = 13)

Change from baseline (SE)

0.3 (1.85)

− 3.2 (1.91)

− 3.9 (1.72)

Difference from placebo (95% CI)

− 3.5 (− 6.24, − 0.79)

− 4.2 (− 6.94, − 1.46)

P value

0.01

0.004

United Kingdom (n = 36)

(n = 11)

(n = 13)

(n = 12)

Change from baseline (SE)

− 1.3 (1.98)

− 6.1 (1.87)

− 4.8 (1.94)

Difference from placebo (95% CI)

− 4.7 (− 8.88, − 0.54)

− 3.5 (− 7.79, 0.82)

P value

0.03

0.11