Measured by units of improvement in SGRQ scores at Baseline and 12 weeks, as well as review of treatment failure status at 4 weeks and 12 weeks of treatment (treatment failure is defined by an increase in lower respiratory symptoms necessitating treatment with active, long-acting inhaled bronchodilator, corticosteroids or antibiotics).

A 4 unit change is the minimum clinically important difference. SGRQ has a 0 - 100 score; 0 as low symptoms (feeling better) and 100 as high symptoms (feeling worse).

In the treatment arm, 5 subjects had primary efficacy assessment >=4 weeks after the last visit that were not included in the mITT (233 - 5 = 228). One additional subject was missing SGRQ at final visit (228 - 1 = 227). In the placebo arm, 5 subjects had primary efficacy assessment >=4 weeks after the last visit that were not included in the mITT (248 - 5 = 243). An additional person did not complete final visit but had treatment failure so are still included in mITT (243 + 1 = 244).

Proportion of individuals with a 2 unit improvement in CAT without treatment failure

In the treatment arm, 5 subjects had primary efficacy assessment >=4 weeks after the last visit that were not included in the mITT (233 - 5 = 228). One additional subject was missing SGRQ at final visit (228 - 1 = 227). In the placebo arm, 5 subjects had primary efficacy assessment >=4 weeks after the last visit that were not included in the mITT (248 - 5 = 243). An additional person did not complete final visit but had treatment failure so are still included in mITT (243 + 1 = 244).

Proportion of individuals with a 1 unit improvement in the BDI/TDI without treatment failure

Not all participants had all measures measured.

Measured by units of improvement in SGRQ scores at Baseline and 12 weeks, as well as review of treatment failure status at 4 weeks and 12 weeks of treatment (treatment failure is defined by an increase in lower respiratory symptoms necessitating treatment with active, long-acting inhaled bronchodilator, corticosteroids or antibiotics).

Not all participants had all measures measured.

Value at 12 Weeks Minus Baseline. SGRQ has a 0 - 100 score; 0 as low symptoms (feeling better) and 100 as high symptoms (feeling worse).

In the treatment arm, 5 subjects had primary efficacy assessment >=4 weeks after the last visit that were not included in the mITT (233 - 5 = 228). One additional subject was missing SGRQ at final visit (228 - 1 = 227). In the placebo arm, 5 subjects had primary efficacy assessment >=4 weeks after the last visit that were not included in the mITT (248 - 5 = 243). .

Value at 12 Weeks Minus Baseline. 0 - 40; 0 as low symptoms (feeling better) and 40 as high symptoms (feeling worse).

In the treatment arm, 5 subjects had primary efficacy assessment >=4 weeks after the last visit that were not included in the mITT (233 - 5 = 228). One additional subject was missing CAT at final visit (228 - 1 = 227). In the placebo arm, 5 subjects had primary efficacy assessment >=4 weeks after the last visit that were not included in the mITT (248 - 5 = 243).

Value at 12 Weeks Minus Baseline.

Not all participants had these measures taken.

FEV1 AUC0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in liters.

Not all persons completed their lung function tests.

Trough FEV1 at 12 week minus trough FEV1 at baseline.

Not all participants had all measures measured.

Change from baseline in 12 hour trough inspiratory capacity - absolute value

Not all participants had all measures measured.

Percentage of days with symptoms (shortness of breath, chest tightness, wheezing, cough, or sputum) or use of albuterol

Not all participants submitted complete diaries.

Treatment failure defined by increase in lower respiratory symptoms necessitating treatment with active, long-acting inhaled bronchodilator, corticosteroids or antibiotics

In the treatment arm, 5 subjects had primary efficacy assessment >=4 weeks after the last visit that were not included in the mITT (233 - 5 = 228). One additional subject was missing SGRQ at final visit (228 - 1 = 227). In the placebo arm, 5 subjects had primary efficacy assessment >=4 weeks after the last visit that were not included in the mITT (248 - 5 = 243). An additional person did not complete final visit but had treatment failure so are still included in mITT (243 + 1 = 244).

Trough FEV1 at 12 week minus trough FEV1 at baseline.

Not all participants had all measures measured.

FEF25-75%-Forced expiratory flow over the middle one half of the FVC; the average flow from the point at which 25 percent of the FVC has been exhaled to the point at which 75 percent of the FVC has been exhaled.

Not all participants had pulmonary function tests.