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. 2019 Feb 26;14:479–491. doi: 10.2147/COPD.S185502

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© 2019 D’UrzoUrzo et al. This work is published and licensed by Dove Medical Press Limited

The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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Efficacy endpoints at week 24 analyzed by airflow obstruction severity (moderate vs severe).

Notes: (A) LS mean change from baseline in morning pre-dose (trough) FEV₁;^a (B) LS mean change from baseline in morning 1-hour post-dose FEV ;^{a 1} (C) LS mean TDI focal score;^a (D) HCRU exacerbation rate (moderate/severe) per patient/year;^b and (E) EXACT exacerbation rate per patient/year^b (pooled ITT population). *P<0.05; **P<0.01; and ***P<0.001. ^aAnalysis based on the mixed model for repeated measures. ^bAnalysis based on the negative binomial regression model. Error bars represent 95% CI.

Abbreviations: AB, aclidinium bromide; EXACT, EXAcerbations of Chronic pulmonary disease Tool; FF, formoterol fumarate; HCRU, healthcare resource utilization; ITT, intent-to-treat; LS, least squares; PBO, placebo; TDI, Transition Dyspnea Index.

Efficacy endpoints at week 24 analyzed by airflow obstruction severity (moderate vs severe).

Notes: (A) LS mean change from baseline in morning pre-dose (trough) FEV₁;^a (B) LS mean change from baseline in morning 1-hour post-dose FEV ;^{a 1} (C) LS mean TDI focal score;^a (D) HCRU exacerbation rate (moderate/severe) per patient/year;^b and (E) EXACT exacerbation rate per patient/year^b (pooled ITT population). *P<0.05; **P<0.01; and ***P<0.001. ^aAnalysis based on the mixed model for repeated measures. ^bAnalysis based on the negative binomial regression model. Error bars represent 95% CI.

Abbreviations: AB, aclidinium bromide; EXACT, EXAcerbations of Chronic pulmonary disease Tool; FF, formoterol fumarate; HCRU, healthcare resource utilization; ITT, intent-to-treat; LS, least squares; PBO, placebo; TDI, Transition Dyspnea Index.