Date

2020-01-06

Protocol

Protocol changed

Item Changed

Secondary outcome(s)

Previous Version

1. Change from baseline in diffusing capacity for carbon monoxide (DLCO) at 6 and12 months of treatment initiation. [At baseline and then at 6 months and 12 months after initiating the treatment ] 2. Change from baseline in Forced Vital Capacity (FVC) at 6 and 12 months of treatment initiation. [At baseline and then at 6 months and 12 months after initiating the treatment ] 3. Change in 6-minute walk distance after 6 and 12 months of treatment initiation. [At baseline and then at 6 months and 12 months after initiating the treatment ] 4. Assessment of improvement in quality of life by using SF-36 [At baseline and then at 6 months and 12 months after initiating the treatment ]

Next Version

1. Change from baseline in Forced Vital Capacity (FVC) at 6 and 12 months of treatment initiation. 2. Change in 6-minute walk distance after 6 and 12 months of treatment initiation. 3. Assessment of improvement in quality of life by using SF-36