- Chest x-ray reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on chest x-ray (e.g. significant cardiomegaly, pleural effusion or scarring). All subjects will have a chest x-ray at Screening (V1) [or historical radiograph or CT scan obtained within 12 months prior to Screening. Subjects who have experienced pneumonia and/or moderate or severe COPD exacerbation within 12 months of Screening (V1) must provide a post pneumonia/exacerbation chest x-ray or have a chest x-ray conducted at Screening (V1)].