araag2/HINT huggingface dataset:
Clinical trial NCT00004099 (phase 3, status: terminated)
Conditions: gastric cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: cisplatin, fluorouracil, leucovorin calcium
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1
Reason stopped: 
    low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically proven stage II-IV adenocarcinoma of the stomach including cardia
             carcinoma types II and III

               -  Locally resectable disease

               -  No distant metastases except M1 lymph nodes

               -  No evidence of peritoneal carcinomatosis

                    -  Free tumor cells in lavage at laparoscopy allowed

          -  No uncontrolled bleeding of the primary tumor

          -  No gastric outlet syndrome or complete tumor stenosis that would require total
             parenteral nutrition

        PATIENT CHARACTERISTICS:

        Age:

          -  18 to 69

        Performance status:

          -  WHO 0-1

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  WBC greater than 4,000/mm^3

          -  Absolute neutrophil count greater than 2,000/mm^3

          -  Platelet count greater than 100,000/mm^3

        Hepatic:

          -  Bilirubin no greater than 1.25 times upper limit of normal (ULN)

          -  Prothrombin rate at least 70%

        Renal:

          -  Creatinine no greater than 1.25 times ULN

          -  Creatinine clearance greater than 60 mL/min

        Cardiovascular:

          -  No prior atrial or ventricular arrhythmias

          -  No prior congestive heart failure

          -  No myocardial infarction within the past 6 months

        Other:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other prior or concurrent neoplasm except curatively treated nonmelanoma skin
             cancer or carcinoma in situ of the cervix

          -  No active infection

          -  No allergy to protocol drugs

          -  No dementia or significantly altered mental status

          -  No other serious medical condition that would prevent compliance

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No filgrastim (G-CSF) within 48 hours prior to chemotherapy

        Chemotherapy:

          -  No prior chemotherapy

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  No prior radiotherapy

        Surgery:

          -  See Disease Characteristics

          -  No prior stent implantation

          -  No prior laser therapy
Clinical trial NCT00357279 (phase 3, status: completed)
Conditions: cystic fibrosis
ICD codes: E84.9, Z14.1, E84.0, E84.11, E84.8, E84.19, P09.4
Drugs: denufosol tetrasodium (ins37217) inhalation solution, placebo - 0.9% w/v sodium chloride solution
SMILES: [H]N([H])C1=NC(=O)N(C=C1)[C@H]1C[C@H](O)[C@@H](COP(O)(=O)OP(O)(=O)OP(O)(=O)OP(O)(=O)OC[C@H]2O[C@H]([C@H](O)[C@@H]2O)N2C=CC(=O)N([H])C2=O)O1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Have confirmed diagnosis of cystic fibrosis

          -  Have FEV1 of greater than or equal to 75% of predicted normal for age, gender, and
             height

          -  Be able to reproducibly perform spirometry maneuvers

          -  Be clinically stable for at least 4 weeks prior to screening

        Exclusion Criteria:

          -  Have abnormal renal or liver function

          -  Have chest x-ray at screening suggesting clinically significant active pulmonary
             disease

          -  Be colonized with Burkholderia cepacia

          -  Have had a lung transplant
Clinical trial NCT00277498 (phase 3, status: completed)
Conditions: open angle glaucoma, ocular hypertension
ICD codes: H40.10X0, H40.10X1, H40.10X2, H40.10X3, H40.10X4, H40.1130, H40.1131, H40.053, H40.051, H40.052, H40.059
Drugs: xalacom, xalatan, timolol
SMILES: CC(C)OC(=O)CCC\C=C/C[C@H]1[C@@H](O)C[C@@H](O)[C@@H]1CC[C@@H](O)CCC1=CC=CC=C1, CC(C)OC(=O)CCC\C=C/C[C@H]1[C@@H](O)C[C@@H](O)[C@@H]1CC[C@@H](O)CCC1=CC=CC=C1, [H][C@](O)(CNC(C)(C)C)COC1=NSN=C1N1CCOCC1
Eligibility criteria:

        Inclusion Criteria:

          -  Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on
             beta-blocker monotherapy or dual therapy in which at least one medication is a
             beta-blocker for at least 4 weeks prior to screening

        Exclusion Criteria:

          -  Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma.

          -  History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months
             prior to screening
Clinical trial NCT00106522 (phase 3, status: completed)
Conditions: rheumatoid arthritis
ICD codes: M06.9, M05.9, M06.08, M06.00, M06.011, M06.012, M06.019
Drugs: methotrexate, placebo, tocilizumab [roactemra/actemra], tocilizumab [roactemra/actemra]
SMILES: CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  adult patients at least 18 years of age with moderate to severe active RA for at least
             6 months;

          -  inadequate response to current anti-rheumatic therapies, including MTX;

          -  inadequate response or intolerance to treatment with 1 or more anti-TNF therapies
             within 1 year of entering study;

          -  on stable MTX for at least 8 weeks before entering study;

          -  patients of reproductive potential must be using reliable methods of contraception.

        Exclusion Criteria:

          -  major surgery (including joint surgery) within 8 weeks before screening, or planned
             major surgery within 6 months after entering study;

          -  women who are pregnant or breast-feeding.
Clinical trial NCT00389064 (phase 3, status: completed)
Conditions: anxiety disorders
ICD codes: F41.1, F41.9, F40.9, F43.22, F41.0, F93.0, F12.980
Drugs: quetiapine xr, placebo
SMILES: OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients, 66 years or older, with a documented clinical diagnosis of
             Generalised Anxiety Disorder (GAD).

          -  Absence of current episode of major depression.

        Exclusion Criteria:

          -  The presence of dementia or other mental disorder than GAD.

          -  Serious suicidal risk, uncontrolled hypertension, substance or alcohol abuse.

          -  A current diagnosis of cancer or current or past diagnosis of stroke.
Clinical trial NCT01142193 (phase 3, status: completed)
Conditions: epilepsy
ICD codes: G40.803, G40.804, G40.911, G40.919, G40.B11, G40.B19, G40.801
Drugs: usl255, placebo
SMILES: [H][C@@]12CO[C@@]3(COS(N)(=O)=O)OC(C)(C)O[C@@]3([H])[C@]1([H])OC(C)(C)O2, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a confirmed diagnosis of partial-onset seizures with or without secondary
             generalization for at least 12 months prior to Visit 1.

          -  Currently on a stable dosing regimen of 1 to 3 AEDs for at least 4-weeks prior to
             Visit 1 (12 weeks for phenobarbital and primidone).

          -  Have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure
             free days, during the 8-week baseline.

        Exclusion Criteria:

          -  Have a history of seizure episodes lasting less than 30 minutes in which several
             seizures occur with such frequency that the initiation and completion of each
             individual seizure cannot be distinguished, within 3 months prior to Visit 1.

          -  Have a history of pseudoseizures, or status epilepticus, within 3 months prior to
             Visit 1.

          -  Have a history of metabolic acidosis, nephrolithiasis, ureterolithiasis, or narrow
             angle glaucoma.

          -  Have a history of suicidal attempts, suicidal ideation, or uncontrolled psychiatric
             illness within 2 years of Visit 1.

          -  Currently taking, or have taken felbamate within the past 18 months, or have taken
             vigabatrin in the past.

          -  Have taken topiramate within the past 6 months.
Clinical trial NCT01375374 (phase 3, status: terminated)
Conditions: epilepsy, partial
ICD codes: G40.111, G40.119, G40.211, G40.219, G40.101, G40.109, G40.201
Drugs: lacosamide, levetiracetam
SMILES: COC[C@@H](NC(C)=O)C(=O)NCC1=CC=CC=C1, CC(C)CC1=CC=C(C=C1)C(C)C(O)=O
Reason stopped: 
    slow progress despite recruitment boosting efforts e.g., expert advice obtained from leading
    study center investigators; decision thus made to terminate.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Male subject with diagnosis of Epilepsy with Partial-Onset Seizures

          -  Subject only taking Levetiracetam in combination with Carbamazepine as adjunctive
             treatment for Epilepsy

        Exclusion Criteria:

          -  Subject is taking another Anti-Epileptic Drug (AED) than Carbamazepine (CBZ) and
             Levetiracetam (LEV)

          -  Subject is taking lipid lowering agents

          -  Subject is taking enzyme inducers
Clinical trial NCT00436553 (phase 3, status: completed)
Conditions: macular degeneration, choroidal neovascularization
ICD codes: H35.30, H35.353, H35.351, H35.352, H35.359, H35.3130, H35.3230, H44.2A1, H44.2A2, H44.2A3, H44.2A9, H35.3231, H35.3232, H35.3211
Drugs: verteporfin photodynamic therapy, ranibizumab, verteporfin placebo, ranibizumab placebo
SMILES: COC(=O)CCC1=C2NC(\C=C3/N=C(/C=C4\N\C(=C/C5=N/C(=C\2)/C(CCC(O)=O)=C5C)C(C=C)=C4C)C2=CC=C([C@@H](C(=O)OC)[C@@]32C)C(=O)OC)=C1C, CN\C(NCCSCC1=CC=C(CN(C)C)O1)=C/[N+]([O-])=O, COC(=O)CCC1=C2NC(\C=C3/N=C(/C=C4\N\C(=C/C5=N/C(=C\2)/C(CCC(O)=O)=C5C)C(C=C)=C4C)C2=CC=C([C@@H](C(=O)OC)[C@@]32C)C(=O)OC)=C1C, CN\C(NCCSCC1=CC=C(CN(C)C)O1)=C/[N+]([O-])=O
Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either gender age 50 years or older

          -  Subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration
             (AMD)

        Exclusion Criteria:

          -  Choroidal neovascularization due to causes other than AMD

          -  Prior treatment for neovascular AMD in the study eye

        Other protocol-defined inclusion/exclusion criteria may apply
Clinical trial NCT00679627 (phase 3, status: terminated)
Conditions: alzheimer's disease
ICD codes: G30.8, G30.9, G30.0, G30.1
Drugs: galantamine, placebo
SMILES: [H][C@]12C[C@@H](O)C=C[C@]11CCN(C)CC3=C1C(O2)=C(OC)C=C3, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    due to a pre-specified imbalance of deaths between treatment groups, the dsmb recommended early
    termination of the trial
  
Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients

          -  diagnosed with mild to moderately-severe, probable or possible AD, established in
             accordance with the criteria defined by the National Institute of Neurological and
             Communicative Disorders and Stroke and Alzheimer's Disease Related Disorders
             Association or the Diagnostic and Statistical Manual, Fourth Edition

          -  living with or have regular and frequent visits from a responsible caregiver.

        Exclusion Criteria:

          -  Neurodegenerative disorders other than AD, such as Parkinson's Disease, Frontotemporal
             Dementia or Huntington's disease

          -  Any of specified conditions which may contribute to dementia

          -  any of specified coexisting diseases, including significant cardiovascular disease.
Clinical trial NCT00448591 (phase 3, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: bevacizumab [avastin], taxane-based chemotherapy
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@]12C[C@H](NC(=O)C[C@H](O)C(C)(C)C(=O)[C@H](C)[C@@H](O)[C@@H](C)CCC[C@@]1(C)O2)C(\C)=C\C1=CSC(C)=N1
Eligibility criteria:

        Inclusion Criteria:

          -  patients, >=18 years of age;

          -  HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic
             disease; (HER-2 positive patients only if previously treated with Herceptin in the
             adjuvant setting;

          -  candidates for chemotherapy.

        Exclusion Criteria:

          -  previous chemotherapy for metastatic or locally recurrent breast cancer;

          -  concomitant hormonal therapy for metastatic or locally recurrent disease;

          -  concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2
             positive disease;

          -  previous radiotherapy for treatment of metastatic disease;

          -  evidence of CNS metastases.
Clinical trial NCT01078675 (phase 3, status: completed)
Conditions: familial hypercholesterolaemia
ICD codes: D75.0, E78.01, E83.31, A81.83, M11.18, G12.24, G90.1
Drugs: rosuvastatin calcium, rosuvastatin calcium, rosuvastatin calcium
SMILES: CC(C)C1=NC(=NC(C2=CC=C(F)C=C2)=C1\C=C\[C@@H](O)C[C@@H](O)CC(=O)O)N(C)S(C)(=O)=O, CC(C)C1=NC(=NC(C2=CC=C(F)C=C2)=C1\C=C\[C@@H](O)C[C@@H](O)CC(=O)O)N(C)S(C)(=O)=O, CC(C)C1=NC(=NC(C2=CC=C(F)C=C2)=C1\C=C\[C@@H](O)C[C@@H](O)CC(=O)O)N(C)S(C)(=O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  children and adolescents (aged 6 to less than 18 years) with Familial
             Hypercholesterolaemia

          -  Patients aged between 6 and less than 10 years of age must not be taking a statin
             medicine

        Exclusion Criteria:

          -  History of muscle or sensitivity reactions to any statin medicines

          -  Current active liver disease or dysfunction (except a confirmed diagnosis of Gilbert's
             disease)
Clinical trial NCT00309088 (phase 3, status: completed)
Conditions: myasthenia gravis
ICD codes: P94.0, G70.00, G70.01
Drugs: tacrolimus, placebo
SMILES: COC1=CC2=C(C(OC)=C1OC)C1=CC=C(OC)C(=O)C=C1C(CC2)NC(C)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Clinically diagnosed as myasthenia gravis

          -  Those whose MG symptoms are well-controlled by the treatment with prednisone

          -  Steroid non-refractory Myasthenia Gravis: ≧20mg and ≦40mg / alternate day of steroid
             dose required to maintain

        Exclusion Criteria:

          -  Those who have thymoma or the history of thymoma (Masaoka stage III or IV)

          -  Patients who received steroid pulse therapy, plasma exchange therapy, globulin therapy
             or radiation therapy within 12 weeks prior to the initiation of test drug

          -  Patients who started the immunosuppressant therapy or increased the dose of
             immunosuppressant within 12 weeks prior to the initiation of test drug.

          -  Patients who had undergone thymectomy within 24 weeks prior to the initiation of test
             drug.

          -  Pancreatitis or diabetes

          -  Serum creatinine≦1.5mg/dL
Clinical trial NCT01556165 (phase 3, status: completed)
Conditions: parkinson's disease
ICD codes: G20
Drugs: rasagiline, placebo
SMILES: C#CCN[C@@H]1CCC2=CC=CC=C12, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Patients with idiopathic PD.

          -  Patients with a Modified Hoehn and Yahr stage <3.

        Exclusion Criteria:

          -  Patients with a clinically significant or unstable medical or surgical condition that
             would preclude his/her safe and complete study participation.

          -  Patients with a clinically significant or unstable vascular disease.

          -  Patients with a clinically significant psychiatric illness, including a major
             depression, which compromises their ability to provide consent or participate fully in
             the study.

          -  Patients with a Mini Mental State Examination (MMSE) score ≤24.

          -  Patients with a diagnosis of melanoma or a history of melanoma, or a suspicious
             lesion.

        Other inclusion and exclusion criteria may apply.
Clinical trial NCT00522379 (phase 3, status: completed)
Conditions: parkinson's disease
ICD codes: G20
Drugs: rotigotine, rotigotine, rotigotine, rotigotine
SMILES: CCCN(CCC1=CC=CS1)[C@H]1CCC2=C(O)C=CC=C2C1, CCCN(CCC1=CC=CS1)[C@H]1CCC2=C(O)C=CC=C2C1, CCCN(CCC1=CC=CS1)[C@H]1CCC2=C(O)C=CC=C2C1, CCCN(CCC1=CC=CS1)[C@H]1CCC2=C(O)C=CC=C2C1
Eligibility criteria:

        Inclusion Criteria:

          -  PD greater than 3 years

          -  Stable dose L-dopa but symptoms not adequately controlled and have "off" time

          -  Able and willing to complete diary on specific days

        Exclusion Criteria:

          -  Previous use of rotigotine or Neupro

          -  Atypical Parkinson's syndrome

          -  Pallidotomy

          -  Thalamotomy

          -  Deep brain stimulation

          -  Fetal tissue transplant

          -  Dementia

          -  Psychosis

          -  Hallucinations

          -  Epilepsy

          -  Renal or hepatic dysfunction

          -  Clinically relevant cardiac dysfunction

          -  Symptomatic orthostatic hypotension

          -  Skin sensitivity to adhesives or unresolved contact dermatitis

          -  History of chronic alcohol or drug abuse

          -  Pregnant or of child-bearing potential

          -  Impulse control disorder
Clinical trial NCT01423253 (phase 3, status: completed)
Conditions: major depressive disorder
ICD codes: F33.0, F33.1, F33.9, F32.0, F32.1, F32.9, F33.40
Drugs: lurasidone
SMILES: [H][C@@]12[C@H]3CC[C@H](C3)[C@]1([H])C(=O)N(C[C@@H]1CCCC[C@H]1CN1CCN(CC1)C1=NSC3=CC=CC=C13)C2=O
Eligibility criteria:

        Inclusion Criteria:

        Subject provides written informed consent and is willing and able to comply with the
        protocol in the opinion of the Investigator.

        Subject has completed 6 weeks of treatment in Study D1050304 (NCT#01421134) or Study
        D1050305 (NCT#01423240).

        Subject is judged by the Investigator to be suitable for participation in a 12-week
        clinical trial involving open-label lurasidone treatment and is able to comply with the
        protocol in the opinion of the Investigator.

        Exclusion Criteria:

        Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of
        evaluation) at baseline (Day 43 in Study D1050304 or D1050305).

        Subject is considered by the Investigator to be at imminent risk of suicide or injury to
        self, others, or property.
Clinical trial NCT00265616 (phase 3, status: terminated)
Conditions: status epilepticus
ICD codes: G40.803, G40.804, G40.823, G40.824, G40.833, G40.834, G40.911
Drugs: propofol, thiopental/pentobarbital
SMILES: OC(=O)[C@@H]1CCCN1, CCCC(C)C1(CC)C(=O)NC(=S)NC1=O
Reason stopped: 
    insufficient recruitment
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients with refractory status epilepticus not due to cerebral anoxia, needing coma
             induction for clinical management.

        Exclusion Criteria:

          -  Age < 16 years old.

          -  Known pregnancy.

          -  Cerebral anoxia as SE etiology.

          -  Epilepsia partialis continua (simple partial SE).

          -  Known intolerance to the study drugs.

          -  Known mitochondrial disorder, hyperlipidemia, or significant rhabdomyolysis.
Clinical trial NCT00356967 (phase 3, status: completed)
Conditions: smoking
ICD codes: O99.334, O99.335, Y93.G2, O99.330, O99.331, O99.332, O99.333
Drugs: dianicline
SMILES: C1C[C@@]23C[N@@]1CC[C@@H]2OC1=C(C3)N=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients over the legal age smoking at least 10 cigarettes per day for at least 2
             months

        Exclusion Criteria:

          -  Insufficient level of motivation

          -  Another participant in the household

          -  Patients with current psychotic disorder or major depressive disorder

        The investigator will evaluate whether there are other reasons why a patient may not
        participate.
Clinical trial NCT01335477 (phase 3, status: completed)
Conditions: pulmonary fibrosis
ICD codes: J84.10, J84.112, E84.0, J84.178
Drugs: placebo, bibf 1120
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, COC(=O)C1=CC=C2C(NC(=O)\C2=C(/NC2=CC=C(C=C2)N(C)C(=O)CN2CCN(C)CC2)C2=CC=CC=C2)=C1
Eligibility criteria:

        Inclusion criteria:

          1. Age >= 40 years;

          2. IPF diagnosed, according to most recent American Thoracic Society (ATS), European
             Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic
             Association (ALAT) IPF guideline for diagnosis and management, within 5 years;

          3. Combination of High Resolution Computerized Tomography (HRCT) pattern, and if
             available surgical lung biopsy pattern, as assessed by central reviewers, are
             consistent with diagnosis of IPF

          4. Dlco (corrected for Hb): 30%-79% predicted of normal; 5.FVC>= 50% predicted of normal

        Exclusion criteria:

          1. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit
             of Normal (ULN)

          2. Bilirubin > 1.5 x ULN;

          3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7);

          4. Patient likely to have lung transplantation during study (being on transplantation
             list is acceptable for participation);

          5. Myocardial infarction within 6 months;

          6. Unstable angina within 1 month;

          7. Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic
             anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event
             within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or
             ulcers or major injury or surgery within 3 months);

          8. Thrombotic risk (inherited predisposition; history of thrombotic event (including
             stroke and transient ischemic attacks) within 12 months;

          9. International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and
             partial thromboplastin time (PTT) by > 50% of institutional ULN);

         10. N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit
             1;

         11. Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of
             visit 1;