- Clinically significant pulmonary symptoms and signs, any active pulmonary or respiratory infection at enrollment, pulmonary infiltrates on screening CT scan of the chest that are associated with symptoms (including dyspnea), resting or exercise arterial oxygen saturation (SpO2) less than (<) 90 percent (%), requirement for supplementary oxygen at rest or exercise (either continuously or intermittently), moderate (40%-60% predicted) or severe (<40% predicted) decreased diffusing capacity for carbon monoxide (DLCO) or mild (>60% </= lower limit of normal [LLN]% predicted) decrease with clinically significant symptoms