araag2/HINT huggingface dataset:
Clinical trial NCT01888107 (phase 3, status: completed)
Conditions: schizophrenia, schizoaffective disorder
ICD codes: F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, F20.9, F25.9, F25.0, F25.1, F25.8
Drugs: risperidone long-acting injectable (lai) 25 mg, risperidone lai 37.5 mg, risperidone lai 50 mg
SMILES: OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12, OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12, OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12
Eligibility criteria:

        Inclusion Criteria:

          -  Schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical
             Manual of Mental Disorders, Fourth Edition (DSM-IV)

          -  Required long-term antipsychotic therapy at the time of recruitment

          -  Symptomatically stable and taking the same dose of antipsychotic agents for at least
             one month before the baseline visit (considered stable if there have been no
             appreciable change in symptoms over the previous month, regardless of the severity of
             their symptoms)

          -  Patients or their legal representatives provided their written informed consent prior
             to enrollment in the study

        Exclusion Criteria:

          -  Patients who had received clozapine during the previous 3 months

          -  Participated in an investigational drug trial in the previous 30 days

          -  Previously been shown to be either intolerant or non-responsive to risperidone therapy

          -  Presence of a serious unstable medical condition, such as a history or current
             symptoms of tardive dyskinesia or a history of neuroleptic malignant syndrome

          -  Pregnant or breast-feeding; female patients of childbearing potential not using
             adequate contraception
Clinical trial NCT00112554 (phase 3, status: completed)
Conditions: leukemia
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: cytarabine, laromustine
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, CNC(=O)N(N(CCCl)S(C)(=O)=O)S(C)(=O)=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed acute myeloid leukemia (AML)

               -  Any WHO classification, excluding acute promyelocytic leukemia

               -  At least 10% blasts by bone marrow aspirate and/or biopsy

          -  In first relapse after achieving a first complete response (CR) OR CR (with platelet
             count < 100,000/mm³ but ≥ 20,000/mm³ [transfusion independent for ≥ 7 consecutive
             days]) (CRp) that lasted ≥ 3 months but ≤ 24 months after completion of the initial
             induction regimen

               -  Relapse confirmed by recurrence of blasts in peripheral blood, bone marrow
                  histopathology, and/or histologically confirmed CNS or extramedullary disease

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  See Disease Characteristics

        Hepatic

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST ≤ 3 times ULN

          -  Chronic hepatitis allowed

        Renal

          -  Creatinine ≤ 2.0 mg/dL

        Cardiovascular

          -  No myocardial infarction within the past 3 months

          -  No uncontrolled arrhythmias

          -  No uncontrolled congestive heart failure

        Pulmonary

          -  No severe chronic obstructive pulmonary disease

          -  No requirement for supplemental oxygen at rest

        Immunologic

          -  No uncontrolled active infection

               -  Infections that are controlled and under active treatment with antibiotics
                  allowed

          -  No evidence of invasive fungal infection by blood or tissue cultures

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

          -  No clinical evidence of another active malignancy by tumor marker, pathology, or
             radiologic studies

          -  No other severe medical condition that would preclude study treatment

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  At least 12 hours since prior hydroxyurea

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  Not specified

        Surgery

          -  Not specified

        Other

          -  No prior treatment while in first relapse except hydroxyurea

          -  No other concurrent standard or investigational treatment for AML

          -  No concurrent disulfiram (Antabuse®)
Clinical trial NCT00530946 (phase 3, status: completed)
Conditions: hypertension, hypercholesterolemia
ICD codes: I15.0, I97.3, K76.6, P29.2, G93.2, H40.053, I10, E78.01, E78.00, Z83.42
Drugs: amlodipine 2.5mg/atorvastatin 5mg, amlodipine 2.5mg/atorvastatin 10mg, amlodipine 5mg/atorvastatin 5mg, amlodipine 5mg/atorvastatin 10mg
SMILES: COC(=O)C1=C(C)NC(C)=C(C1C1=CC(=CC=C1)[N+]([O-])=O)C(=O)OC(C)(C)CN(C)CCC(C1=CC=CC=C1)C1=CC=CC=C1, COC(=O)C1=C(C)NC(C)=C(C1C1=CC(=CC=C1)[N+]([O-])=O)C(=O)OC(C)(C)CN(C)CCC(C1=CC=CC=C1)C1=CC=CC=C1, COC(=O)C1=C(C)NC(C)=C(C1C1=CC(=CC=C1)[N+]([O-])=O)C(=O)OC(C)(C)CN(C)CCC(C1=CC=CC=C1)C1=CC=CC=C1, COC(=O)C1=C(C)NC(C)=C(C1C1=CC(=CC=C1)[N+]([O-])=O)C(=O)OC(C)(C)CN(C)CCC(C1=CC=CC=C1)C1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male
             or female >=20 to <80 years of age at Visit 1.

          -  The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP >=140 mmHg and
             <180 mmHg,

          -  LDL-C >=140 mg/dL and <250 mg/dL at Visit 3 (Week -2) and 4 (Week -1).

        Exclusion Criteria:

          -  Subjects who had experienced the following coronary artery disease within the past 3
             months.

          -  Myocardial infarction

          -  Receiving PCI（percutaneous coronary intervention）or CABG (coronary artery bypass
             grafting)

          -  Any clinically meaningful valvular disease

          -  Subjects with a history of cerebrovascular diseases such as stroke or transient
             ischemic attack within the past 3 months.
Clinical trial NCT00647127 (phase 3, status: completed)
Conditions: pain
ICD codes: N50.82, R07.2, R07.82, R10.13, R10.33, R14.1, R52
Drugs: buprenorphine, fentanyl, placebo
SMILES: NCC1(CC(O)=O)CCCCC1, [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  written informed consent

          -  men > 18 years

        Exclusion Criteria:

          -  women

          -  known allergy against the investigated drugs

          -  ongoing participation in other experiments or participation in other experiments 14
             days before screening

          -  previously pain or psychiatric conditions

          -  simultaneously use of pain killers

          -  alcohol

          -  previously drug-addict or member of family with drug-addicts

          -  chronic constipation

          -  ileus

          -  inflammatory bowel syndrome

          -  abdominal surgery within the last three months
Clinical trial NCT00279916 (phase 3, status: completed)
Conditions: otitis media, serous, negative middle ear pressure, rhinitis, otitis media with effusion, otitis media, secretory
ICD codes: H65.03, H65.23, H65.00, H65.01, H65.02, H65.06, H65.20, A41.50, A41.59, E70.320, Z17.1, Z67.11, Z67.21, Z67.31, J30.0, J31.0, J30.89, J30.9, A50.05, J30.2, J30.1, J94.0, I31.3, J91.0, M25.40, M25.411, M25.412, M25.419
Drugs: triamcinolone acetonide nasal spray, placebo nasal spray
SMILES: [H]\C(=C(\[H])C1=CC=C(OC)C=C1)C(=O)OCC(CC)CCCC, 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, age 0-18 years

          -  Patients with serous otitis media and/or negative middle ear pressure as documented by
             otoscopic examination and tympanometry will be considered for enrollment

          -  Pregnant

        Exclusion Criteria:

          -  Unwilling to discontinue breast feeding, when applicable

          -  Active upper respiratory infection

          -  Nasopharyngeal mass

          -  Chronic infectious otitis media

          -  Cholesteatoma

          -  Acute infectious otitis media

          -  History of otologic surgery other than placement of a pressure equalizer tube in the
             affected ear

          -  History of radiation therapy to the head and neck region

          -  Neuromuscular disease

          -  Cystic fibrosis

          -  Immunodeficiency

          -  Mucociliary disorders

          -  Craniofacial disorders/syndromes

          -  Cleft palate

          -  Development delay and/or symptoms suggestive of perilymph fistula
Clinical trial NCT00360568 (phase 3, status: completed)
Conditions: dyskinesias, parkinson's disease, severe motor fluctuations
ICD codes: G20
Drugs: levodopa-carbidopa intestinal gel
SMILES: C[C@@](CC1=CC(O)=C(O)C=C1)(NN)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Idiopathic Parkinson's disease (PD) according to United Kingdon Parkinson's Disease
             Society (UKPDS) Brain Bank Criteria

          -  Levodopa-responsive with severe motor fluctuations

          -  Completion of protocol S187.3.001 (NCT00357994) or S187.3.002 (NCT00660387) and
             continue to meet the inclusion criteria for the preceding study

        Exclusion Criteria:

          -  Patients with medically relevant abnormal findings (labs, electrocardiogram [ECG],
             physical examination, adverse events, psychiatric, neurological or behavioral
             disorders, etc.) at end of the double-blind phase (Week 12) of Study S187.3.001
             (NCT00357994) or Study S187.3.002 (NCT00660387)
Clinical trial NCT01282151 (phase 3, status: terminated)
Conditions: carcinoma, non small cell lung
ICD codes: D02.20, D02.21, D02.22
Drugs: taxotere, pemetrexed
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H], [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Reason stopped: 
    difficulty in recruitment due to approval of maintenance pemetrexed treatment
  
Eligibility criteria:

        Inclusion Criteria:

          -  Age >= 18 years old

          -  ECOG performance status 0-2

          -  Non-squamous cell type non-small cell lung cancer (NSCLC)

          -  Stage IV, Stage IIIB cannot be treated with curative intent or Relapsed after surgery
             or radiation therapy

          -  No prior chemotherapy except adjuvant chemotherapy and concurrent chemoradiation
             treatment. The last dose of adjuvant chemotherapy should be at least 6 months earlier
             from randomization, and the regimen should not contain docetaxel or pemetrexed.

          -  No prior immunotherapy, biologic therapy

          -  Measurable lesion with Response Evaluation Criteria in Solid Tumors (RECIST) version
             1.1

          -  Hemoglobin >=9.0g/dl, Platelet >=100,000/uL, neutrophil >=1,500 /uL Creatinine <=1.5 x
             upper normal limit or creatinine clearance >=60 mL/min Bilirubin <=1.5 x upper normal
             limit, Transaminases <=2 x upper normal limit Alkaline phosphatase <=2 x upper normal
             limit

          -  Written informed consent

        Exclusion Criteria:

          -  Pregnancy, Lactating woman

          -  Woman in child bearing age who refuses to do pregnancy test

          -  Moderate or greater than grade 1 motor or sensory neurotoxicity

          -  Hypersensitivity to taxane

          -  Comorbidity or poor medical conditions

          -  Other malignancy (except cured basal cell carcinoma or uterine cervical carcinoma in
             situ)

          -  Concurrent treatment with other investigational drugs within 30 days before
             randomization

          -  Active treatment with other anticancer chemotherapy

          -  EGFR mutation (exon 19 deletion, L858R, L861Q, G719A/C/S)
Clinical trial NCT00657501 (phase 3, status: completed)
Conditions: hypoactive sexual desire disorder
ICD codes: F52.0
Drugs: testosterone gel, placebo gel
SMILES: [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C, [H][C@@]12[C@@H](C)C3=C(C(O)=CC=C3)C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])[C@H]2O
Eligibility criteria:

        Inclusion Criteria:

          -  Must be between the ages of 30 to 65 years

          -  Must have undergone hysterectomy and bilateral salpingo-oophorectomy

        Exclusion Criteria:

          -  A history of allergic reactions to androgens (oral or patch), topical alcohol, or any
             component of the formulation

          -  Any systemic skin diseases or local skin abnormalities in the area of application

          -  Diagnosed with another primary female sexual dysfunction (e.g., Sexual Aversion
             Disorder, Female Sexual Arousal Disorder).

          -  A medical condition that could affect or interfere with sexual function

          -  Using a systemic transdermal gel or cream estrogen therapy.
Clinical trial NCT00264537 (phase 3, status: completed)
Conditions: rheumatoid arthritis
ICD codes: M06.9, M05.9, M06.08, M06.00, M06.011, M06.012, M06.019
Drugs: placebo injections, placebo capsules, methotrexate capsules
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, 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
Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria
             of the ACR) for at least 3 months prior to first administration of study agent

          -  Are methotrexate (MTX)-naïve (ie, have not received more than 3 weekly doses of MTX
             for RA at any time)

          -  Have active RA as defined by persistent disease activity with at least 4 swollen and 4
             tender joints, at the time of screening and baseline, and at least 2 of the following
             4 criteria: a) C-reactive protein (CRP) >=1.5 mg/dL at screening or erythrocyte
             sedimentation rate (ESR) by Westergren method of >= 28 mm in the first hour at
             screening or baseline, b)Morning stiffness of >= 30 minutes at screening and baseline,
             c)Bone erosion by x-ray and/or MRI prior to first administration of study agent,
             d)Anti-cyclic citrullinated peptide (anti-CCP) antibody-positive or rheumatoid factor
             (RF) positive at screening

          -  If using oral corticosteroids, must be on a stable dose equivalent to <= 10 mg of
             prednisone/day for at least 2 weeks prior to first administration of study agent.

        Exclusion Criteria:

          -  Can not have inflammatory diseases other than RA that might confound the evaluation of
             the benefit of golimumab therapy

          -  No treatment with disease-modifying anti-rheumatic drugs (DMARDs)/systemic
             immunosuppressives during the 4 weeks prior to the first administration of study agent

          -  No prior treatment with biologic anti-TNF drugs (infliximab, etanercept, adalimumab)

          -  No history of, or ongoing, chronic or recurrent infectious disease

          -  No serious infection within 2 months prior to first administration of study agent.
Clinical trial NCT01106690 (phase 3, status: completed)
Conditions: diabetes mellitus, type 2
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: placebo, canagliflozin, sitagliptin, metformin, pioglitazone
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][C@]1(O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O)C1=CC=C(C)C(CC2=CC=C(S2)C2=CC=C(F)C=C2)=C1, N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F, CSCC[C@H](N)C(O)=O, N[C@@H](CCCNC(N)=N)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have a diagnosis of T2DM and be currently treated with PPAR gamma
             agent ((pioglitazone or rosiglitazone) and another anti-diabetes agent (metformin)

          -  Patients in the study must have a HbA1c between >=7 and <=10.5% and a fasting plasma
             glucose (FPG) <270 mg/dL (15 mmol/L)

        Exclusion Criteria:

          -  History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta
             cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy

          -  or a severe hypoglycemic episode within 6 months before screening
Clinical trial NCT00314860 (phase 3, status: completed)
Conditions: restless legs syndrome, restless legs syndrome (rls)
ICD codes: G25.81, G25.81, R45.1
Drugs: ropinirole extended release (xr)
SMILES: CCCN(CCC)CCC1=C2CC(=O)NC2=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and
             International Restless Legs Syndrome Study Group Diagnostic Criteria.

          -  Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time
             (between 8:00 pm and 8:00 am) symptoms requiring treatment.

        Exclusion criteria:

          -  Signs of secondary RLS.

          -  Primary sleep disorder or movement disorder other than RLS.

          -  Unstable medical conditions.

          -  Inability to tolerate dopamine agonists or dopamine antagonists.

          -  Unwilling to discontinue any medications currently being taken to treat RLS symptoms.
Clinical trial NCT00131391 (phase 3, status: terminated)
Conditions: obesity
ICD codes: E66.8, E66.9, E66.1, O99.214, O99.215, O99.210, O99.211
Drugs: comparator: taranabant, comparator: placebo
SMILES: C[C@H](NC(=O)C(C)(C)OC1=CC=C(C=N1)C(F)(F)F)[C@@H](CC1=CC=C(Cl)C=C1)C1=CC=CC(=C1)C#N, CN(C)C(=N)NC(N)=N
Reason stopped: 
    the overall profile does not support development for obesity
  
Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index (BMI) between 30-43 kg/m2

        Exclusion Criteria:

          -  History of major psychiatric disorder

          -  History of seizures or at high risk of developing seizures

          -  Blood pressure greater than 160/100

          -  Fasting blood glucose greater than 126 mg/dL

          -  Triglycerides greater than 600 mg/dL
Clinical trial NCT00065507 (phase 3, status: completed)
Conditions: hepatitis b
ICD codes: B18.0, B18.1, B19.10, B19.11, B17.0, B16.0, B16.1
Drugs: entecavir (etv), adefovir (adv)
SMILES: NC1=NC(=O)C2=C(N1)N(C=N2)[C@H]1C[C@H](O)[C@@H](CO)C1=C, CC(C)(C)C(=O)OCOP(=O)(COCCN1C=NC2=C(N)N=CN=C12)OCOC(=O)C(C)(C)C
Eligibility criteria:

        Inclusion

          -  Child-Pugh (CP) score >= 7

          -  Hepatitis B virus (HBV) viremia

        Exclusion

          -  Alanine aminotransferase (ALT) > 15 x upper limit of normal (ULN)

          -  Human immunodeficiency virus (HIV)/hepatitis C virus (HCV)/hepatitis D virus (HDV)
             coinfection
Clinical trial NCT00309686 (phase 3, status: completed)
Conditions: affective psychosis, bipolar, bipolar disorder, mania
ICD codes: F31.81, F31.89, F31.9, F25.0, F31.0, F31.31, F31.32
Drugs: paliperidone er
SMILES: CC1=C(CCN2CCC(CC2)C2=NOC3=C2C=CC(F)=C3)C(=O)N2CCCC(O)C2=N1
Eligibility criteria:

        Inclusion Criteria:

          -  Meets Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV)
             criteria for Bipolar I Disorder, Most Recent Episode Manic or Mixed (with or without
             psychotic features)

          -  History of at least 1 previously documented manic or mixed episode requiring medical
             treatment within the past 3 years

          -  Must have been taking lithium or valproate as part of treatment for Bipolar I Disorder
             for at least 2 weeks before screening, with drug levels at screening within
             therapeutic range

          -  Total YMRS score of at least 20 at screening and at baseline (Day 1)

          -  Women must be postmenopausal for at least 2 years or agree to practice an effective
             method of birth control throughout the study.

        Exclusion Criteria:

          -  Meets DSM-IV criteria for rapid cycling and schizoaffective disorder

          -  In the opinion of the study doctor, is at significant risk for suicidal or violent
             behavior during the course of the study

          -  Has used cocaine, phencyclidine, amphetamine, methylphenidate, pemoline, an opioid
             (excluding codeine), hallucinogen, or any other drug that may be associated with manic
             symptoms as evidenced by a positive urine drug screen

          -  Has received benzodiazepines at doses equal to 4 mg/day of lorazepam or higher for a
             period of 3 months or longer immediately before the screening phase.
Clinical trial NCT00546286 (phase 3, status: completed)
Conditions: glaucoma, ocular hypertension
ICD codes: H40.9, Q15.0, B73.02, H40.823, H40.89, H44.513, H40.821, H40.053, H40.051, H40.052, H40.059
Drugs: dorzolamide hydrochloride (+) timolol maleate, comparator: dorzolamide hcl/timolol maleate + prostaglandin
SMILES: CCN[C@H]1C[C@H](C)S(=O)(=O)C2=C1C=C(S2)S(N)(=O)=O, CCN[C@H]1C[C@H](C)S(=O)(=O)C2=C1C=C(S2)S(N)(=O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Patient has been recently diagnosed and is presently untreated for Open-Angle Glaucoma
             Or Ocular Hypertension With An iop of at least 27 mmhg in at least one eye (patient's
             worse eye)

          -  Patient Already Diagnosed With Open-Angle Glaucoma Or Ocular Hypertension And
             Untreated For At Least 30 Days Are Eligible For The Study If They Have An Iop Of 27
             Mmhg Or More In At Least One Eye

        Exclusion Criteria:

          -  A History Of Any Illness That, In The Opinion Of The Investigator, Might Confound The
             Results Of The Study Or Pose Additional Risk By Administering Dorzolamide-Timolol
             (Cosopt®) Or Prostaglandins

          -  The Presence Of Any Fundus Pathology Likely To Change During The Study Or To Influence
             Iop (Background Of Diabetic Retinopathy Is Permitted)

          -  Any Contraindication To The Use Of Cosopt® Including: - Bronchospasm, Including
             Bronchial Asthma Or A History Of Bronchial Asthma Or Chronic Obstructive Pulmonary
             Disease. - Sinus Bradycardia, Second Or Third Degree Av Block, Cardiac Failure (Grade
             Iii And Iv), Cardiogenic Shock

          -  Patient On Oral Carbonic Anhydrase Inhibitor, Concomitant Systemic Or Dermatological
             Medication Known To Affect The Iop, E.G. Clonidine, Corticosteroids, Oral
             Beta-Blocking Agents

          -  Pregnant Woman Or A Woman Of Childbearing Potential Who Is Sexually Active And Not
             Using An Acceptable Method Of Contraception (For Ex: Oral Contraceptive, Diaphragm,
             Contraceptive Sponge, Intra-Uterine Device, Long-Acting Contraceptive Injections,
             Double-Barrier Methods) Beginning At Least 7 Days Prior To Treatment And Continuing At
             Least 14 Days After The Last Visit Or The Discontinuation Visit. (Women Who Are
             Postmenopausal Or Have Received A Hysterectomy Or Have Undergone Tubal Ligature Are
             Considered As Not Having Childbearing Potential.)

          -  Severe Renal Impairment (Serum Creatinine > 150 umol/L Or Creatinine Clearance < 30
             ml/min)