Visit: 0

  • Week: -4
  • Day: -28

Administrative

  • ☐ Informed Consent / Assent
  • ☐ Inclusion / Exclusion Criteria
  • ☐ Dispense (return) diaries
  • ☐ Diary Completion (Assessment)
  • ☐ Email / Telephone Monitoring

Safety

  • ☐ Medical History
  • ☐ Concomitant Therapies
  • ☐ Spirometry: Pre-Study Drug

Efficacy

  • ☐ Lung Volumes: Pre-Study Drug
  • ☐ Exercise oximetry (clinic)
  • ☐ WHOQOL
  • ☐ Dyspnea & Fatigue Score

Visit: 1

  • Week: 0
  • Day: 0

Administrative

  • ☐ Diary Completion (Assessment)
  • ☐ Email / Telephone Monitoring
  • ☐ Drug Administration
  • ☐ Drug Administration Log

Safety

  • ☐ Medical History
  • ☐ Concomitant Therapies
  • ☐ Adverse Events
  • ☐ Vital Signs
  • ☐ Physical Examination
  • ☐ Clinical Laboratory Tests
  • ☐ Spirometry: Pre-Study Drug
  • ☐ Spirometry: Post-Study Drug
  • ☐ Chest X-Ray

Efficacy

  • ☐ Lung Volumes: Pre-Study Drug
  • ☐ Limited Chest HRCT
  • ☐ Exercise oximetry (clinic)
  • ☐ Serum Biomarkers
  • ☐ WHOQOL
  • ☐ Dyspnea & Fatigue Score

Visit: 2

  • Week: 4
  • Day: 28

Administrative

  • ☐ Diary Completion (Assessment)
  • ☐ Email / Telephone Monitoring
  • ☐ Drug Administration
  • ☐ Drug Administration Log

Safety

  • ☐ Medical History
  • ☐ Concomitant Therapies
  • ☐ Adverse Events
  • ☐ Vital Signs
  • ☐ Physical Examination
  • ☐ Clinical Laboratory Tests

Efficacy

  • ☐ WHOQOL
  • ☐ Dyspnea & Fatigue Score

Visit: 3

  • Week: 8
  • Day: 56

Administrative

  • ☐ Diary Completion (Assessment)
  • ☐ Email / Telephone Monitoring
  • ☐ Drug Administration
  • ☐ Drug Administration Log

Safety

  • ☐ Medical History
  • ☐ Concomitant Therapies
  • ☐ Adverse Events
  • ☐ Vital Signs
  • ☐ Physical Examination
  • ☐ Clinical Laboratory Tests
  • ☐ Spirometry: Pre-Study Drug

Efficacy

  • ☐ Lung Volumes: Pre-Study Drug
  • ☐ Exercise oximetry (clinic)
  • ☐ WHOQOL
  • ☐ Dyspnea & Fatigue Score

Visit: 4

  • Week: 12
  • Day: 84

Administrative

  • ☐ Diary Completion (Assessment)
  • ☐ Email / Telephone Monitoring
  • ☐ Drug Administration
  • ☐ Drug Administration Log

Safety

  • ☐ Medical History
  • ☐ Concomitant Therapies
  • ☐ Adverse Events
  • ☐ Vital Signs
  • ☐ Physical Examination
  • ☐ Clinical Laboratory Tests
  • ☐ Spirometry: Pre-Study Drug

Efficacy

  • ☐ Lung Volumes: Pre-Study Drug
  • ☐ Exercise oximetry (clinic)
  • ☐ Serum Biomarkers
  • ☐ WHOQOL
  • ☐ Dyspnea & Fatigue Score

Visit: 5

  • Week: 16
  • Day: 112

Administrative

  • ☐ Diary Completion (Assessment)
  • ☐ Email / Telephone Monitoring
  • ☐ Drug Administration
  • ☐ Drug Administration Log

Safety

  • ☐ Medical History
  • ☐ Concomitant Therapies
  • ☐ Adverse Events
  • ☐ Vital Signs
  • ☐ Physical Examination
  • ☐ Clinical Laboratory Tests
  • ☐ Chest X-Ray

Efficacy

  • ☐ WHOQOL
  • ☐ Dyspnea & Fatigue Score

Visit: 6

  • Week: 20
  • Day: 140

Administrative

  • ☐ Diary Completion (Assessment)
  • ☐ Email / Telephone Monitoring
  • ☐ Drug Administration
  • ☐ Drug Administration Log

Safety

  • ☐ Medical History
  • ☐ Concomitant Therapies
  • ☐ Adverse Events
  • ☐ Vital Signs
  • ☐ Physical Examination
  • ☐ Clinical Laboratory Tests
  • ☐ Spirometry: Pre-Study Drug

Efficacy

  • ☐ Lung Volumes: Pre-Study Drug
  • ☐ Exercise oximetry (clinic)
  • ☐ WHOQOL
  • ☐ Dyspnea & Fatigue Score

Visit: 7

  • Week: 24
  • Day: 168

Administrative

  • ☐ Diary Completion (Assessment)
  • ☐ Email / Telephone Monitoring
  • ☐ Drug Administration
  • ☐ Drug Administration Log

Safety

  • ☐ Medical History
  • ☐ Concomitant Therapies
  • ☐ Adverse Events
  • ☐ Vital Signs
  • ☐ Physical Examination
  • ☐ Clinical Laboratory Tests
  • ☐ Spirometry: Pre-Study Drug

Efficacy

  • ☐ Lung Volumes: Pre-Study Drug
  • ☐ Exercise oximetry (clinic)
  • ☐ Serum Biomarkers
  • ☐ WHOQOL
  • ☐ Dyspnea & Fatigue Score

Visit: 8

  • Week: 28
  • Day: 196

Administrative

  • ☐ Diary Completion (Assessment)
  • ☐ Email / Telephone Monitoring
  • ☐ Drug Administration
  • ☐ Drug Administration Log

Safety

  • ☐ Medical History
  • ☐ Concomitant Therapies
  • ☐ Adverse Events
  • ☐ Vital Signs
  • ☐ Physical Examination
  • ☐ Clinical Laboratory Tests

Efficacy

  • ☐ Limited Chest HRCT
  • ☐ WHOQOL
  • ☐ Dyspnea & Fatigue Score

Visit: 9

  • Week: 32
  • Day: 224

Administrative

  • ☐ Diary Completion (Assessment)
  • ☐ Email / Telephone Monitoring
  • ☐ Drug Administration
  • ☐ Drug Administration Log

Safety

  • ☐ Medical History
  • ☐ Concomitant Therapies
  • ☐ Adverse Events
  • ☐ Vital Signs
  • ☐ Physical Examination
  • ☐ Clinical Laboratory Tests
  • ☐ Spirometry: Pre-Study Drug
  • ☐ Chest X-Ray

Efficacy

  • ☐ Lung Volumes: Pre-Study Drug
  • ☐ Exercise oximetry (clinic)
  • ☐ WHOQOL
  • ☐ Dyspnea & Fatigue Score

Visit: 10

  • Week: 36
  • Day: 252

Administrative

  • ☐ Diary Completion (Assessment)
  • ☐ Email / Telephone Monitoring
  • ☐ Drug Administration
  • ☐ Drug Administration Log

Safety

  • ☐ Medical History
  • ☐ Concomitant Therapies
  • ☐ Adverse Events
  • ☐ Vital Signs
  • ☐ Physical Examination
  • ☐ Clinical Laboratory Tests
  • ☐ Spirometry: Pre-Study Drug

Efficacy

  • ☐ Lung Volumes: Pre-Study Drug
  • ☐ Exercise oximetry (clinic)
  • ☐ Serum Biomarkers
  • ☐ WHOQOL
  • ☐ Dyspnea & Fatigue Score

Visit: 11

  • Week: 40
  • Day: 280

Administrative

  • ☐ Diary Completion (Assessment)
  • ☐ Email / Telephone Monitoring
  • ☐ Drug Administration
  • ☐ Drug Administration Log

Safety

  • ☐ Medical History
  • ☐ Concomitant Therapies
  • ☐ Adverse Events
  • ☐ Vital Signs
  • ☐ Physical Examination
  • ☐ Clinical Laboratory Tests

Efficacy

  • ☐ WHOQOL
  • ☐ Dyspnea & Fatigue Score

Visit: 12

  • Week: 44
  • Day: 308

Administrative

  • ☐ Diary Completion (Assessment)
  • ☐ Email / Telephone Monitoring
  • ☐ Drug Administration
  • ☐ Drug Administration Log

Safety

  • ☐ Medical History
  • ☐ Concomitant Therapies
  • ☐ Adverse Events
  • ☐ Vital Signs
  • ☐ Physical Examination
  • ☐ Clinical Laboratory Tests
  • ☐ Spirometry: Pre-Study Drug

Efficacy

  • ☐ Lung Volumes: Pre-Study Drug
  • ☐ Exercise oximetry (clinic)
  • ☐ WHOQOL
  • ☐ Dyspnea & Fatigue Score

Visit: Follow Up

  • Week: 48
  • Day: 336

Administrative

  • ☐ Diary Completion (Assessment)
  • ☐ Email / Telephone Monitoring
  • ☐ Drug Administration Log

Safety

  • ☐ Medical History
  • ☐ Concomitant Therapies
  • ☐ Adverse Events
  • ☐ Vital Signs
  • ☐ Physical Examination
  • ☐ Clinical Laboratory Tests
  • ☐ Spirometry: Pre-Study Drug
  • ☐ Chest X-Ray

Efficacy

  • ☐ Lung Volumes: Pre-Study Drug
  • ☐ Exercise oximetry (clinic)
  • ☐ Serum Biomarkers
  • ☐ WHOQOL
  • ☐ Dyspnea & Fatigue Score

Visit: Early Termination

  • Week: 52
  • Day: 364

Administrative

  • ☐ Diary Completion (Assessment)

Safety

  • ☐ Medical History
  • ☐ Concomitant Therapies
  • ☐ Adverse Events
  • ☐ Vital Signs
  • ☐ Physical Examination
  • ☐ Clinical Laboratory Tests
  • ☐ Spirometry: Pre-Study Drug
  • ☐ Chest X-Ray

Efficacy

  • ☐ Lung Volumes: Pre-Study Drug
  • ☐ Exercise oximetry (clinic)
  • ☐ Serum Biomarkers
  • ☐ WHOQOL
  • ☐ Dyspnea & Fatigue Score