Table 2 Treatment differences for change from baseline in trough FEV₁ (L) at Week 12 (Efficacy population)

Overall

N

203

1,210

1,215

n^†

193

1,201

1,203

LS mean change from baseline (SE)

0.120 (0.0333)

0.301 (0.0116)

0.225 (0.0116)

Difference vs placebo (95 % CI)

–

0.181* (0.111–0.252)

0.105* (0.034–0.175)

Difference vs FF 100 μg (95 % CI)

–

0.077* (0.045–0.108)

–

Japan

N

19

47

46

n^†

18

46

46

LS mean change from baseline (SE)

−0.022 (0.0955)

0.301 (0.0590)

0.194 (0.0591)

Difference vs placebo (95 % CI)

–

0.323 (0.104–0.542)

0.216 (−0.003–0.436)

Difference vs FF 100 μg (95 % CI)

–

0.107 (−0.056–0.270)

–

Not-Japan

N

184

1,163

1,169

n^†

175

1,155

1,157

LS mean change from baseline (SE)

0.133 (0.0345)

0.301 (0.0118)

0.226 (0.0118)

Difference vs placebo (95 % CI)

–

0.168 (0.095–0.241)

0.093 (0.020–0.166)

Difference vs FF 100 μg (95 % CI)

–

0.075 (0.043–0.108)

–