Table 3.

Timing and Reasons for Withdrawal from Treatment, Including Deaths

Reason for Withdrawal	Active (n = 40) [n (%)]	Placebo (n = 20) [n (%)]	P Value
Withdrawal after baseline	8 (20)	1 (5)	0.25
SAE	2	0	0.55
Withdrew consent	1	0	1
Protocol violation: pulmonary embolism	2	0	0.55
Protocol violation: severe obstructive sleep apnea	1	0	1
Protocol violation: bronchogenic carcinoma	0	1	1
Death	2	0	0.55
Withdrawal after Week 4	1 (2.5)	2 (10)	1
Withdrew consent	1	1	1
Death	0	1	1
Withdrawal after Week 8	1 (2.5)	3 (15)	0.10
SAE	1	0	1
Lung transplant	0	1	0.33
Death	0	2	0.11
Withdrawal after Week 12	4 (10)	0 (0)	0.29
SAE	2	0	0.55
Progression of underlying fibrotic lung disease	1	0	1
Death	1	0	1
Total	14 (35)	6 (30)

Definition of abbreviation: SAE = serious adverse event.