araag2/HINT huggingface dataset:
Clinical trial NCT00227370 (phase 3, status: completed)
Conditions: cytomegalovirus infections
ICD codes: P35.1
Drugs: valganciclovir
SMILES: CC(C)[C@H](N)C(=O)OCC(CO)OCN1C=NC2=C1NC(N)=NC2=O
Eligibility criteria:

        Inclusion Criteria for Phase I:

          -  Adult lung transplant recipients age 18 or older

          -  At risk for CMV (donor or recipient serology must be positive for CMV)

          -  Adequate hematological and renal function,

          -  On intravenous (IV) ganciclovir within 24 hours of surgery

          -  Agreement to use effective methods of contraception

          -  Negative pregnancy

          -  Tolerate oral medications within 2 weeks of transplant

          -  Negative baseline CMV PCR

          -  Able to understand and sign the informed consent

        Exclusion Criteria for Phase 1:

          -  Repeat transplantation

          -  Mechanical ventilation at study entry

          -  Oral or intravenous ganciclovir treatment outside the study protocol

          -  Invasive fungal infection

          -  Participation in another investigational study

          -  Acute CMV infection or disease

          -  Anti-CMV therapy within 30 days before enrollment

          -  Uncontrolled diarrhea or malabsorption

          -  Allergic reaction to study drug

          -  Required use of prohibited medications

          -  Lactating women

          -  Pregnancy

          -  Renal failure

        Inclusion Criteria for Phase II:

          -  Negative serial post transplant PCRs at day 75

          -  Negative bronchial cultures for CMV

          -  Adequate hematological and renal function at day 75

          -  IV ganciclovir for up to 2 weeks post operation and open label up to day 90

          -  Effective contraceptives

          -  Negative pregnancy

        Exclusion Criteria Phase II:

          -  Renal failure

          -  Serious adverse events (SAE) related to study drug

          -  CMV disease (study endpoint)

          -  Withdraw consent for Phase II
Clinical trial NCT00433160 (phase 3, status: completed)
Conditions: osteoporosis
ICD codes: M81.6, Z82.62, Z13.820, M81.8, Z87.310, M81.0, M80.80XS
Drugs: teriparatide, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Japanese patients diagnosed with osteoporosis

          -  Aged 55 or older

          -  Patients who are at high risk for fracture

        Exclusion Criteria:

          -  History of metabolic bone disorders other than primary osteoporosis

          -  History of malignant neoplasm in the 5 years, with the exception of superficial basal
             cell carcinoma or squamous cell carcinoma of the skin that has been definitively
             treated.

          -  Severe or chronically disabling conditions other than osteoporosis
Clinical trial NCT00569530 (phase 3, status: completed)
Conditions: respiratory distress syndrome of prematurity (surfactant dysfunction), bronchopulmonary dysplasia
ICD codes: P27.1
Drugs: infasurf (ony inc.), sham
SMILES: CC1=CC(O)=CC(C)=C1Cl
Eligibility criteria:

        Inclusion Criteria:

          -  Less than or equal to 1000 gm. birth weight

          -  Less than or equal to 30 weeks gestational age

          -  Day 7-14 of life

          -  Intubated and mechanically ventilated at any time days 7-14 of life

        Exclusion Criteria:

          -  Serious congenital malformations

          -  Life expectancy less than 7 days from enrollment

          -  Previous treatment with iNO

          -  Active pulmonary hemorrhage at time of enrollment

          -  Active air leak syndrome at time of enrollment

          -  Bilateral grade IV intracranial hemorrhage prior to enrollment

          -  Less than 48 hours from last clinical dose of early surfactant.
Clinical trial NCT00666458 (phase 3, status: completed)
Conditions: type 2 diabetes
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: saxagliptin, sitagliptin
SMILES: N[C@H](C(=O)N1[C@H]2C[C@H]2C[C@H]1C#N)C12CC3CC(CC(O)(C3)C1)C2, N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes

          -  Treatment with metformin alone on stable doses of 1500 mg or higher per day for at
             least 8 weeks

        Exclusion Criteria:

          -  Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketotic coma

          -  Insulin therapy within one year

          -  Previous treatment with DPP-4 inhibitor
Clinical trial NCT00263042 (phase 3, status: terminated)
Conditions: cardiovascular disease
ICD codes: A52.00, A52.09, A50.54, Z01.810, Q87.418, Z13.6, R94.30
Drugs: rimonabant, placebo (for rimonabant)
SMILES: CC1=C(N(N=C1C(=O)NN1CCCCC1)C1=C(Cl)C=C(Cl)C=C1)C1=CC=C(Cl)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    company decision taken in light of demands by certain national health authorities
  
Eligibility criteria:

        Inclusion Criteria:

        Waist circumference >102 cm (40 inches) males, >88 cm (35 inches) females, with one
        coronary heart disease (CHD) equivalent or two major risk factors for cardiovascular
        disease.

          -  CHD equivalents:

               -  Recent (within 3 years)documented heart attack

               -  Documented symptomatic coronary artery disease

               -  Recent (within 3 years) ischemic cerebrovascular episode (stroke or TIA)

               -  Documented symptomatic peripheral arterial disease

          -  Major risk factors:

               -  Documented type 2 diabetes mellitus

               -  Metabolic syndrome (NCEP criteria)

               -  Asymptomatic cerebrovascular, renal, or peripheral arterial disease, or past
                  abdominal aortic aneurysm repair

               -  Elevated high-sensitivity C-reactive protein

               -  Age > or = 65 years for males, age > or = 70 years for females

        Exclusion Criteria:

          -  Obesity of known endocrine origin

          -  Pregnant or breastfeeding women

          -  Very low calorie diet or weight loss surgery within past 6 months

          -  Presence of any severe medical or psychological condition that, in the opinion of the
             investigator, would compromise the patient's safe participation, including
             uncontrolled serious psychiatric illness

          -  Likely cardiovascular intervention within next 1 month

          -  Allergy to rimonabant or excipients, or prior participation in a rimonabant trial

          -  Receipt of investigational product within past 30 days
Clinical trial NCT01054573 (phase 3, status: completed)
Conditions: hepatitis c, chronic
ICD codes: B18.2, B18.0, B18.1, B18.8, B18.9, K71.3, K71.4
Drugs: telaprevir, pegylated interferon (peg-ifn) alfa-2a, ribavirin (rbv)
SMILES: [H][C@@]12CCC[C@]1([H])[C@H](N(C2)C(=O)[C@@H](NC(=O)[C@@H](NC(=O)C1=NC=CN=C1)C1CCCCC1)C(C)(C)C)C(=O)N[C@@H](CCC)C(=O)C(=O)NC1CC1, CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1, NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O
Eligibility criteria:

        Inclusion Criteria:

          -  Patient from the control group of the C216 study who failed therapy for virologic
             reasons

          -  Patient must have completed all assessments in the C216 trial

          -  Patient must be willing to use 2 effective methods of birth control for up to 7 months
             after last dose of study medication

        Exclusion Criteria:

          -  Patient received any direct acting anti-viral HCV therapy after discontinuation of the
             C216 trial

          -  Patient has history of decompensated liver disease

          -  Patient has history of acute or chronic pancreatitis

          -  Patient has condition that requires use of systemic corticosteroids

          -  Patient who prematurely stopped medication for non-compliance or for whom it would be
             unsafe to repeat treatment

          -  Patient has history of decompensated liver disease or history of cirrhosis with
             hepatocellular carcinoma
Clinical trial NCT00128479 (phase 3, status: completed)
Conditions: major depressive disorder, psychotic disorders
ICD codes: F33.0, F33.1, F33.9, F32.0, F32.1, F32.9, F33.40, F23, F24, F12.159, F12.259, F12.150, F12.151, F12.250
Drugs: mifepristone, mifepristone matched placebo, mifepristone 600 mg, mifepristone 1200 mg
SMILES: CO[C@H]1\C=C\O[C@@]2(C)OC3=C(C2=O)C2=C(O)C(\C=N\N4CCN(C)CC4)=C(NC(=O)\C(C)=C/C=C/[C@H](C)[C@H](O)[C@@H](C)[C@@H](O)[C@@H](C)[C@H](OC(C)=O)[C@@H]1C)C(O)=C2C(O)=C3C, CO[C@H]1\C=C\O[C@@]2(C)OC3=C(C2=O)C2=C(O)C(\C=N\N4CCN(C)CC4)=C(NC(=O)\C(C)=C/C=C/[C@H](C)[C@H](O)[C@@H](C)[C@@H](O)[C@@H](C)[C@H](OC(C)=O)[C@@H]1C)C(O)=C2C(O)=C3C, [H][C@@]12CC[C@@](O)(C#CC)[C@@]1(C)C[C@H](C1=CC=C(C=C1)N(C)C)C1=C3CCC(=O)C=C3CC[C@@]21[H], [H][C@@]12CC[C@@](O)(C#CC)[C@@]1(C)C[C@H](C1=CC=C(C=C1)N(C)C)C1=C3CCC(=O)C=C3CC[C@@]21[H]
Eligibility criteria:

        Inclusion Criteria:

        Individuals eligible for enrollment into this study are male and female adult patients who:

          -  Are 18 to 75 years of age

          -  Have a diagnosis of major depressive disorder with psychotic features (DSM-IV 296.24
             or 296.34)

          -  Are able to provide written informed consent.

        Exclusion Criteria:

        Individuals not eligible to be enrolled into the study are those who:

          -  Have a major medical problem

          -  Have previously participated in a CORLUX (C-1073, mifepristone) clinical trial

          -  Have a history of an allergic reaction to CORLUX (C-1073, mifepristone).
Clinical trial NCT00440193 (phase 3, status: completed)
Conditions: venous thrombosis
ICD codes: K64.5, I67.6, O87.3, O22.50, O22.51, O22.52, O22.53
Drugs: rivaroxaban (xarelto, bay59-7939), enoxaparin followed by vka
SMILES: ClC1=CC=C(S1)C(=O)NC[C@H]1CN(C(=O)O1)C1=CC=C(C=C1)N1CCOCC1=O, [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed acute symptomatic proximal DVT without symptomatic PE

        Exclusion Criteria:

          -  Legal lower age limitations (country specific)

          -  Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the
             current episode of DVT and/or PE

          -  Other indication for VKA than DVT and/or PE

          -  The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from
             36 hours to a maximum of 48 hours.
Clinical trial NCT01516424 (phase 3, status: completed)
Conditions: schizophrenia
ICD codes: F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, F20.9
Drugs: blonanserin, risperidone
SMILES: CCN1CCN(CC1)C1=NC2=C(CCCCCC2)C(=C1)C1=CC=C(F)C=C1, OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12
Eligibility criteria:

        Inclusion Criteria:

          -  Subject met Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV-Text
             Revision(TR) criteria for a primary diagnosis of schizophrenia

          -  Patients are 18≤age<65 years of age on the day when informed consent is obtained.

          -  Subject had a PANSS total score ≥70 and 120≥ at Screening

          -  Subject had a score ≥4 on the PANSS at Screening and Baseline.

          -  Subjects are willing and able to comply with study protocol including treatment in
             hospital.

          -  Subjects or their legal guardians have signed the written informed consent form.

        Exclusion Criteria:

          -  The subject was treatment with other Investigate product within 30 days.

          -  Subject had a history of treatment with long-acting drug for anti schizophrenia within
             56 days.

          -  Subject had a history of treatment with clozapine within 28 days.

          -  Subject With parkinson disease,etc
Clinical trial NCT01262677 (phase 3, status: completed)
Conditions: partial seizures, epilepsies, partial
ICD codes: G40.111, G40.119, G40.211, G40.219, G40.101, G40.109, G40.201
Drugs: pregabalin, pregabalin, pregabalin, pregabalin, pregabalin, pregabalin, placebo
SMILES: NCC1(CC(O)=O)CCCCC1, NCC1(CC(O)=O)CCCCC1, NCC1(CC(O)=O)CCCCC1, NCC1(CC(O)=O)CCCCC1, NCC1(CC(O)=O)CCCCC1, NCC1(CC(O)=O)CCCCC1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex,
             with or without evolution into a bilateral, convulsive seizure)

          -  Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have
             taken at least 2 prior (or ongoing) AEDs

        Exclusion Criteria:

          -  Primary generalized seizures (for example, absence, myoclonic seizures or
             Lennox-Gastaut Syndrome)

          -  Status epilepticus within one year prior to screening
Clinical trial NCT00191880 (phase 3, status: completed)
Conditions: attention deficit hyperactivity disorder
ICD codes: F90.2, F90.8, F90.9, F90.0, F90.1
Drugs: atomoxetine
SMILES: CNCC[C@@H](OC1=CC=CC=C1C)C1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

        -Patients must have ADHD, be psychotropic medication naive and be outpatients who are at
        least 8 years of age and not more than 10 years of age at Visit 1 (that is, not yet reached
        their 11 birthday) so that all year testing will be completed before the child reaches age
        12.

        Exclusion Criteria:

        -Patients with current or past history of Bipolar I or II disorder, psychosis, autism,
        Asperger's syndrome, pervasive developmental disorder, conduct disorder, seizure disorder
        or serious suicidal risk are excluded
Clinical trial NCT00089479 (phase 3, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: capecitabine [xeloda], taxotere, taxotere
SMILES: CCCCCOC(=O)NC1=NC(=O)N(C=C1F)[C@@H]1O[C@H](C)[C@@H](O)[C@H]1O, [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H], [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Eligibility criteria:

        Inclusion Criteria:

          -  female patients 18-70 years of age;

          -  adenocarcinoma of the breast;

          -  previous invasive breast cancer if diagnosed >5 years before entering study;

          -  no evidence of metastatic disease.

        Exclusion Criteria:

          -  history of severe hypersensitivity reaction to Taxotere;

          -  previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane;

          -  treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years.
Clinical trial NCT01374308 (phase 3, status: unknown status)
Conditions: chronic hepatitis b
ICD codes: B18.0, B18.1, B18.2, B18.8, B18.9
Drugs: pegylated interferon alpha 2b
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Eligibility criteria:

        Inclusion Criteria:

          -  HBsAg+ serology for more than 6 months before the beginning of the treatment.

        In the last six months, according to HBeAg serostatus, for:

          -  HBeAg (-) patients, with a) baseline HBV DNA ≥ 103 and b) raised serum ALT (x >1 ULN)
             or significant hepatic necroinflammation and/or fibrosis (HAI-NI>4 and/or HAI-F >2) or
             liver stiffness >7.2 KPa.

          -  HBeAg (+) patients, with a) baseline HBV DNA ≥ 104 and b) and raised serum ALT (x >1.5
             ULN) or significant hepatic necroinflammation and or fibrosis (HAI-NI>4 and/or HAI-F
             >2) or liver stiffness >7.2 KPa.

          -  Patients of both sex from 18 to 60 years-old

          -  No specific hepatitis B treatment at least for 6 months previous to the inclusion

          -  Voluntary signed informed consent to participate in the trial

        Exclusion Criteria:

          -  Condition of HBV asymptomatic carrier or cirrhosis or patients with primary
             hepatocellular carcinoma

          -  Positive serological markers for hepatitis C

          -  Positive serological markers for HIV

          -  Previous specific anti-hepatitis B treatment in the last 6 months.

          -  Critically ill patient history of heart or renal failure, hypertension,
             hyperthyroidism, epilepsy, immunodeficiency diseases, malignancies or any
             non-controlled systemic disease.

          -  Pregnancy or nursing women. Women in fertile age without any contraceptive methods.

          -  Known severe allergic conditions (degree III or IV asthma, urticaria, dermatitis,
             bronchitis, etc. or hypersensitivity to any of the ingredients present in the
             preparation).

          -  Severe psychiatric dysfunction or another limitation that prevents the patient's
             consent.

          -  History of Autoimmune diseases (such as SLE, rheumatoid arthritis, multiple sclerosis,
             non controlled diabetes mellitus type 1)

          -  History of other hepatic diseases of different etiology (such as alcoholism,
             autoimmune hepatitis, drug induced hepatitis, Wilson's diseases, hemochromatosis)

          -  History of immune suppressive disorder or administration of immune suppressive-immune
             modulator drugs (including steroids) during or in the 6 months previous to the study.

          -  Very high transaminase levels at the beginning of treatment (ALT over 500 U/L)
             suggesting a not stable disease with risk for patient's health or acute flares over 15
             times the upper limit of normality.
Clinical trial NCT00185211 (phase 3, status: completed)
Conditions: multiple sclerosis
ICD codes: G35, C81.18
Drugs: interferon beta-1b (betaseron, bay86-5046), interferon beta-1b (betaseron, bay86-5046)
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1, CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have reached scheduled end of study in BENEFIT, either by developing CDMS
             or by completing 24 months

        Exclusion Criteria:

          -  No participation in the initial BENEFIT study
Clinical trial NCT00363519 (phase 3, status: completed)
Conditions: type 2 diabetes mellitus
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: placebo, sitagliptin phosphate
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F
Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Type 2 diabetes mellitus on diet/exercise therapy and glimepiride as
             monotherapy

        Exclusion Criteria:

          -  Patients with Type 1 diabetes mellitus
Clinical trial NCT00216060 (phase 3, status: terminated)
Conditions: metastatic prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: risedronate, placebo
SMILES: OC(CC1=CN=CC=C1)(P(O)(O)=O)P(O)(O)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    terminated due to low accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the prostate with
             metastatic bone disease (by CT, MRI or bone scan) with plans to start or be < 30 days
             from beginning androgen deprivation therapy. Patients with lymph node or visceral
             metastases only are not eligible

          -  Patients may receive palliative radiation therapy at the investigators discretion
             during the first 4 weeks of beginning protocol therapy.

        Exclusion Criteria:

          -  No neuroendocrine, small cell or transitional cell cancer of the prostate No abnormal
             bone metabolism (i.e., Paget's disease, untreated hyperthyroidism, untreated
             hyperprolactinemia, untreated Cushing's disease).

          -  No use of calcitonin within 14 days before being registered for protocol therapy or
             any previous use of bisphosphonates.

          -  No major surgery within 4 weeks of registration to protocol therapy.

          -  No adjuvant chemotherapy within 6 months of registration to protocol therapy.

          -  No previous chemotherapy for metastatic disease.

          -  No hormonal therapy in the adjuvant setting within 12 months of registration to
             protocol therapy; previous hormonal therapy must not have exceeded 6 months.

          -  No prior history of malignancy in the past 5 years with the exception of basal cell
             and squamous cell carcinoma of the skin.

          -  No history of allergy or drug reactions to bisphosphonates.
Clinical trial NCT00364845 (phase 3, status: terminated)
Conditions: anemia, chronic kidney disease
ICD codes: D53.2, D64.9, D46.4, D53.0, D53.9, D61.3, D61.9, I12.9, N18.9, I12.0, D63.1, N18.1, N18.5, I13.0
Drugs: darbepoetin alfa, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    the reason for the discontinuation of the study is difficulty with recruitment and timely
    enrolment and is not related to safety concerns
  
Eligibility criteria:

        Inclusion Criteria:

          -  Stage 3-5 CKD not on dialysis

          -  Patients ≥ 70 years of age

          -  Haemoglobin < 110g/L at screening

          -  Transferrin saturation ≥ 15% at screening

        Exclusion Criteria:

          -  Clinical history of type 2 diabetes mellitus

          -  Anticipating or scheduled to go on renal replacement therapy in the next year,
             including renal transplant

          -  Uncontrolled hypertension on two separate measurements during screening

          -  Use of any erythropoietic protein within 12 weeks of screening
Clinical trial NCT02082769 (phase 3, status: completed)
Conditions: gout
ICD codes: M10.9, M10.08, M10.00, M10.011, M10.012, M10.019, M10.021
Drugs: febuxostat, allopurinol
SMILES: CC(C)COC1=C(C=C(C=C1)C1=NC(C)=C(S1)C(O)=O)C#N, O=C1N=CN=C2NNC=C12
Eligibility criteria:

        Inclusion Criteria:

          -  Hyperuricemia (serum urate ≥8.0 mg/dL) and gout by Chinese Rheumatism Association
             Criteria;

          -  Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine
             clearance of > 20 milliliters per minute (mL/min) by Cockcroft and Gault formula;

          -  No gout flare 2 weeks beforehand during 2-week screening period.

        Exclusion Criteria:

          -  Pregnancy or lactation;

          -  Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine,
             thiazide diuretics, or medications containing aspirin (>325 mg) or other salicylates;

          -  Body Mass Index (BMI) >50 kilogram per meter²(kg/m²);

          -  A history of active liver disease, or hepatic dysfunction;

          -  A history of bronchial asthma;

          -  A history of renal calculi or thyroid disease;

          -  Secondary gout Joint diseases induced by rheumatoid arthritis, psoriatic arthritis and
             bone tumor;

          -  Intolerance to allopurinol and Ibuprofen;

          -  Alcohol intake of ≥ 14 drinks/week;

          -  Clinically significant medical condition.