Table S1.
Null and alternative hypotheses
| The superiority of olodaterol to placebo was tested by the comparison of the mean FEV1 AUC0–3 response and the mean trough FEV1 response. As there are two different dose levels of olodaterol (5 μg and 10 μg) and two coprimary end points, the following hypotheses were tested in hierarchical order, each at 2.5% level of significance (one-sided) to protect the overall probability of type I error at 0.025 (one-sided). |
| • Superiority in mean FEV1 AUC0–3 response in patients treated with olodaterol 10 μg compared to those treated with placebo at day 85 (after 12 weeks of treatment) |
| • Superiority in mean trough FEV1 response in patients treated with olodaterol 10 μg compared to those treated with placebo at day 85 (after 12 weeks of treatment) |
| • Superiority in mean FEV1 AUC0–3 response in patients treated with olodaterol 5 μg compared to those treated with placebo at day 85 (after 12 weeks of treatment) |
| • Superiority in mean trough FEV1 response in patients treated with olodaterol 5 μg compared to those treated with placebo at day 85 (after 12 weeks of treatment) |
| Each test was considered confirmatory providing all the previous tests were successful. Otherwise, it was considered as descriptive. |
Abbreviations: FEV1, forced expiratory volume in 1 second; AUC0–3, area under the curve from 0–3 hours.