Exclusions Related to Cardiovascular Disease 
1. History of uncontrolled hypertension 
2. Persistent hypotension at Screening. 
3. Evidence or history of left-sided heart disease and/or clinically significant cardiac disease in which pulmonary hypertension is more likely WHO Group 2. 
4. Acute decompensated heart failure within 1 month of Screening. 
5. Recent initiation (<8 weeks from Screening) or planned initiation of cardiopulmonary rehabilitation exercise program. 
Exclusions Related to Pulmonary Disease 
6. Newly diagnosed with PAH and not on PAH-specific therapy. 
7. Pulmonary hypertension due to: 
1. Uncorrected congenital systemic-to-pulmonary shunt. 
2. Pulmonary veno-occlusive disease and/or pulmonary capillary hemangiomatosis 
3. Persistent pulmonary hypertension of the newborn 
4. WHO clinical classification Groups 2-5 
8. Evidence of significant airway and/or parenchymal lung disease. 
9. Chronic infection related to tuberculosis or fungal or mycobacterial disease. 
Exclusions Based on Other Medical Conditions 
10. Chronic infections including, but not limited to tuberculosis (TB), hepatitis B virus (HBV) or hepatitis C virus (HCV). 
11. History of portal hypertension or chronic liver disease, including positive serology for infection with HCV and/or HBV. 
12. Evidence of active infection requiring intravenous or oral antibiotics within 4 weeks of Screening. 
13. Body mass index ≥35.0 at Screening. 
14. History of obstructive sleep apnea. 
15. History of malignancy within the last 5 years, except nonmelanoma skin cancer and cervical carcinoma in situ treated with curative intent. 
16. Neuropsychiatric disorders/symptoms or psychological conditions. 
17. Pregnancy or breast-feeding 
18. Prior treatment with B cell or lymphocyte-depleting agents (eg, rituximab, Campath) 
Exclusions Based on Concomitant Medication Use 
19. Concurrent regular use of another leukotriene pathway inhibitor, including over-the-counter medications or herbal remedies. 
Exclusions Based on Laboratory Values 
20. Significant/chronic renal insufficiency. 
21. Transaminases (alanine transaminase, aspartate transaminase) levels >3 × upper limit of normal (ULN) and/or bilirubin level >2 × ULN. 
22. Absolute neutrophil count <1500 mm3. 
23. Hemoglobin concentration <9 g/dL at Screening. 
24. Hepatic dysfunction as defined by Child-Pugh Class B or C       
    

NCT02664558_exc_T34
Condition
hypertension
NCT02664558_exc_T35
Qualifier
uncontrolled
NCT02664558_exc_T36
Observation
History
NCT02664558_exc_T37
Condition
Persistent hypotension
NCT02664558_exc_T38
Temporal
at Screening
NCT02664558_exc_T39
Reference_point
Screening
NCT02664558_exc_T40
Observation
history
NCT02664558_exc_T41
Condition
left-sided heart disease
NCT02664558_exc_T42
Condition
cardiac disease
NCT02664558_exc_T43
Qualifier
clinically significant
NCT02664558_exc_T46
Condition
pulmonary hypertension
NCT02664558_exc_T47
Measurement
WHO Group
NCT02664558_exc_T48
Value
2
NCT02664558_exc_T49
Scope
left-sided heart disease and/or clinically significant cardiac disease in which pulmonary hypertension is more likely WHO Group 2
NCT02664558_exc_T50
Condition
heart failure
NCT02664558_exc_T51
Qualifier
decompensated
NCT02664558_exc_T52
Qualifier
Acute
NCT02664558_exc_T53
Temporal
within 1 month of Screening
NCT02664558_exc_T54
Reference_point
Screening
NCT02664558_exc_T55
Temporal
<8 weeks from Screening
NCT02664558_exc_T56
Temporal
Recent
NCT02664558_exc_T57
Reference_point
Screening
NCT02664558_exc_T58
Qualifier
planned
NCT02664558_exc_T60
Procedure
cardiopulmonary rehabilitation exercise program
NCT02664558_exc_T61
Scope
Recent initiation (<8 weeks from Screening) or planned
NCT02664558_exc_T62
Condition
PAH
NCT02664558_exc_T63
Procedure
PAH-specific therapy
NCT02664558_exc_T64
Negation
not
NCT02664558_exc_T65
Temporal
Newly diagnosed
NCT02664558_exc_T67
Condition
congenital systemic-to-pulmonary shunt
NCT02664558_exc_T68
Qualifier
Uncorrected
NCT02664558_exc_T69
Condition
Pulmonary veno-occlusive disease
NCT02664558_exc_T71
Condition
pulmonary capillary hemangiomatosis
NCT02664558_exc_T72
Condition
pulmonary hypertension of the newborn
NCT02664558_exc_T73
Qualifier
Persistent
NCT02664558_exc_T74
Measurement
WHO clinical classification
NCT02664558_exc_T75
Value
Groups 2-5
NCT02664558_exc_T76
Condition
airway disease
NCT02664558_exc_T77
Condition
parenchymal lung disease
NCT02664558_exc_T78
Qualifier
significant
NCT02664558_exc_T79
Scope
airway and/or parenchymal lung disease
NCT02664558_exc_T82
Condition
tuberculosis
NCT02664558_exc_T83
Condition
fungal disease
NCT02664558_exc_T84
Condition
mycobacterial disease
NCT02664558_exc_T85
Multiplier
Chronic
NCT02664558_exc_T86
Condition
infection
NCT02664558_exc_T87
Scope
tuberculosis or fungal or mycobacterial disease
NCT02664558_exc_T88
Observation
related to
NCT02664558_exc_T89
Condition
tuberculosis (TB)
NCT02664558_exc_T90
Condition
hepatitis B virus (HBV)
NCT02664558_exc_T91
Condition
hepatitis C virus (HCV)
NCT02664558_exc_T92
Condition
infections
NCT02664558_exc_T93
Multiplier
Chronic
NCT02664558_exc_T94
Scope
tuberculosis (TB), hepatitis B virus (HBV) or hepatitis C virus (HCV)
NCT02664558_exc_T95
Condition
portal hypertension
NCT02664558_exc_T96
Condition
chronic liver disease
NCT02664558_exc_T97
Measurement
serology for infection with HCV
NCT02664558_exc_T98
Measurement
serology for infection HBV
NCT02664558_exc_T99
Value
positive
NCT02664558_exc_T100
Scope
positive serology for infection with HCV and/or HBV
NCT02664558_exc_T101
Condition
infection requiring antibiotics
NCT02664558_exc_T104
Temporal
within 4 weeks of Screening
NCT02664558_exc_T105
Reference_point
Screening
NCT02664558_exc_T106
Measurement
Body mass index
NCT02664558_exc_T107
Value
≥35.0
NCT02664558_exc_T108
Temporal
at Screening
NCT02664558_exc_T109
Reference_point
Screening
NCT02664558_exc_T110
Condition
obstructive sleep apnea
NCT02664558_exc_T111
Observation
History
NCT02664558_exc_T112
Condition
malignancy
NCT02664558_exc_T114
Temporal
within the last 5 years
NCT02664558_exc_T115
Observation
History
NCT02664558_exc_T116
Condition
nonmelanoma skin cancer
NCT02664558_exc_T117
Negation
except
NCT02664558_exc_T118
Condition
cervical carcinoma in situ
NCT02664558_exc_T119
Procedure
treated
NCT02664558_exc_T120
Qualifier
curative intent
NCT02664558_exc_T121
Condition
Neuropsychiatric disorders
NCT02664558_exc_T123
Condition
psychological conditions
NCT02664558_exc_T124
Condition
Neuropsychiatric symptoms
NCT02664558_exc_T127
Condition
Pregnancy
NCT02664558_exc_T128
Condition
breast-feeding
NCT02664558_exc_T129
Drug
B cell -depleting agents
NCT02664558_exc_T130
Drug
lymphocyte-depleting agents
NCT02664558_exc_T131
Drug
rituximab
NCT02664558_exc_T132
Drug
Campath
NCT02664558_exc_T133
Scope
rituximab, Campath
NCT02664558_exc_T134
Scope
B cell or lymphocyte-depleting agents
NCT02664558_exc_T135
Temporal
Prior
NCT02664558_exc_T136
Drug
leukotriene pathway inhibitor
NCT02664558_exc_T137
Qualifier
another
NCT02664558_exc_T139
Multiplier
regular use
NCT02664558_exc_T141
Temporal
Concurrent
NCT02664558_exc_T142
Condition
chronic renal insufficiency
NCT02664558_exc_T143
Qualifier
Significant
NCT02664558_exc_T145
Measurement
alanine transaminase
NCT02664558_exc_T146
Measurement
aspartate transaminase
NCT02664558_exc_T147
Value
>3 × upper limit of normal (ULN)
NCT02664558_exc_T148
Measurement
Transaminases levels
NCT02664558_exc_T149
Scope
alanine transaminase, aspartate transaminase
NCT02664558_exc_T150
Measurement
bilirubin level
NCT02664558_exc_T151
Value
>2 × ULN
NCT02664558_exc_T152
Measurement
Absolute neutrophil count
NCT02664558_exc_T153
Value
<1500 mm3
NCT02664558_exc_T154
Measurement
Hemoglobin concentration
NCT02664558_exc_T155
Value
<9 g/dL
NCT02664558_exc_T156
Temporal
at Screening
NCT02664558_exc_T157
Reference_point
Screening
NCT02664558_exc_T158
Condition
Hepatic dysfunction
NCT02664558_exc_T159
Measurement
Child-Pugh
NCT02664558_exc_T160
Value
Class B or C