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Samy Suissa, PhD, Amnon Ariel, MD, FCCP  CHEST 

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Presentation on theme: "Samy Suissa, PhD, Amnon Ariel, MD, FCCP  CHEST "— Presentation transcript:

1 US Food and Drug Administration-Mandated Trials of Long-Acting β-Agonists Safety in Asthma 
Samy Suissa, PhD, Amnon Ariel, MD, FCCP  CHEST  Volume 143, Issue 5, Pages (May 2013) DOI: /chest Copyright © 2013 The American College of Chest Physicians Terms and Conditions

2 Figure 1 A single simulation of the expected data for the four adult/adolescent trials under the null hypothesis of no effect (rate ratio = 1) with corresponding estimated rate ratios and 95% CIs for the composite asthma outcome. The CIs for trials 1, 2, and 4 do not cross the threshold value of 2, so that the corresponding long-acting β-agonists (LABAs) would be judged as noninferior, but the CI for trial 3 does cross the threshold value of 2, so the corresponding LABA could not be judged as noninferior. CHEST  , DOI: ( /chest ) Copyright © 2013 The American College of Chest Physicians Terms and Conditions


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