araag2/HINT huggingface dataset:
Clinical trial NCT00621140 (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: linagliptin, placebo
SMILES: [H][C@@]1(CCOC1)OC1=CC=C(CC2=C(Cl)C=CC(=C2)[C@]2([H])O[C@]([H])(CO)[C@@]([H])(O)[C@]([H])(O)[C@@]2([H])O)C=C1, 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 with type 2 diabetes and insufficient glycaemic control.

          -  Age 18 or over and not older than 80 years

        Exclusion criteria:

          -  Use of more than one oral antidiabetic agent within 10 weeks prior to informed
             consent, insulin, glitazones or GLP-1 analogues within 3 months.

          -  Myocardial infarction, stroke or transient ischaemic attack within 6 months prior to
             informed consent.
Clinical trial NCT00129519 (phase 3, status: completed)
Conditions: basal cell carcinoma
ICD codes: C44.510, C44.91, C44.01, C44.311, C44.511, C44.81, C44.41
Drugs: imiquimod 5% cream
SMILES: CC(C)CN1C=NC2=C1C1=CC=CC=C1N=C2N
Eligibility criteria:

        Inclusion Criteria:

          -  Basal cell carcinoma

        Exclusion Criteria:

          -  Psoriasis
Clinical trial NCT01488071 (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: vortioxetine (lu aa21004), agomelatine
SMILES: CC1=CC=C(SC2=CC=CC=C2N2CCNCC2)C(C)=C1, COC1=CC2=C(C=CC=C2CCNC(C)=O)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  The patient is being treated with a serotonin reuptake inhibitor (SRI) antidepressant
             (monotherapy) that was prescribed to treat Major Depressive Episode (DSM-IV-TR
             criteria)

          -  The response to the current SRI treatment is inadequate and patient agrees to
             discontinue the current SRI at the baseline

          -  Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥22 at the Screening
             Visit and Baseline

          -  The patient, if a woman, must: agree not to try to become pregnant during the study,
             AND use adequate, highly effective contraception

        Exclusion Criteria:

          -  The patient has any current Axis I disorders (DSM-IV criteria) other than Major
             Depressive Disorder (MDD), General Anxiety Disorder (GAD) and Social Anxiety Disorder
             (SAD)

          -  The patient is at significant risk of suicide

          -  The patient is currently receiving formal psychotherapy or other psychoactive
             medications

        Other protocol-defined inclusion and exclusion criteria may apply.
Clinical trial NCT00010153 (phase 3, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: fulvestrant
SMILES: [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=CC=C(O)C=C3C[C@@H](CCCCCCCCCS(=O)CCCC(F)(F)C(F)(F)F)[C@@]21[H]
Reason stopped: 
    low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed stage I or II primary operable breast cancer

               -  Surgery planned within next 1-4 weeks

          -  Hormone receptor status:

               -  Estrogen receptor positive or unknown

               -  No known estrogen receptor negative tumor

               -  Unknown progesterone receptor status eligible

        PATIENT CHARACTERISTICS:

        Age:

          -  Any age

        Sex:

          -  Female

        Menopausal status:

          -  Premenopausal or postmenopausal

        Performance status:

          -  Not specified

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  No bleeding diathesis not compatible with an IM depot injection

        Hepatic:

          -  Not specified

        Renal:

          -  Not specified

        Other:

          -  Not pregnant

          -  Negative pregnancy test

          -  Fertile patients must use effective non-hormonal contraception during and for 2-3
             months after study

          -  No other prior or concurrent malignancy except adequately treated basal cell carcinoma
             of the skin or cancer of the uterine cervix

          -  No psychological, familial, sociological, or geographical condition that would
             preclude study

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  Not specified

        Endocrine therapy:

          -  At least 2 months since prior ICI 182780

        Radiotherapy:

          -  No prior radiotherapy to primary tumor

        Surgery:

          -  See Disease Characteristics

        Other:

          -  No other concurrent preoperative therapy for breast cancer
Clinical trial NCT00002976 (phase 3, status: terminated)
Conditions: endometrial cancer
ICD codes: N85.00, N85.01, N85.02, N99.85
Drugs: conjugated estrogens
SMILES: [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=C(CC[C@@]21[H])C=C(O)C=C3
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed grade I, II or III endometrial adenocarcinoma (endometrioid,
             villoglandular, mucinous, adenosquamous, papillary serous, clear cell, or not
             otherwise specified)

          -  Must have had total hysterectomy and bilateral salpingo-oophorectomy within past 20
             weeks

               -  Surgical stage IA, IB, IC, IIA (occult), or IIB (occult) disease

          -  Must have had normal mammogram, or a negative breast biopsy after an abnormal
             mammogram, within past year

        PATIENT CHARACTERISTICS:

        Age:

          -  Not specified

        Performance status:

          -  Not specified

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Not specified

        Hepatic:

          -  Bilirubin no greater than 1.5 times normal

          -  SGOT no greater than 3 times normal

          -  No acute liver disease

        Renal:

          -  Not specified

        Cardiovascular:

          -  No prior thromboembolic disease

        Other:

          -  No prior or current carcinoma of the breast

          -  No other prior invasive malignancy within the past 5 years except nonmelanoma skin
             cancer

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  Not specified

        Endocrine therapy:

          -  No concurrent hormonal therapy

        Radiotherapy:

          -  Not specified

        Surgery:

          -  See Disease Characteristics

          -  Recovered from prior surgery

        Other:

          -  No prior cancer treatment that would preclude study therapy

          -  Concurrent participation on GOG Lap-1 or GOG Lap-2 allowed
Clinical trial NCT00105937 (phase 3, status: completed)
Conditions: pain, cancer
ICD codes: N50.82, R07.2, R07.82, R10.13, R10.33, R14.1, R52, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: oravescent fentanyl citrate
SMILES: [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
Eligibility criteria:

        Inclusion Criteria:

          -  18-80 years of age

          -  Average of 1-4 breakthrough pain episodes per day

          -  Opioid tolerant

          -  Histologically documented diagnosis of a malignant solid tumor or hematological
             malignancy

        Exclusion Criteria:

          -  Primary breakthrough pain is not related to cancer in any way

          -  Opioid or fentanyl intolerance

          -  Chronic obstructive pulmonary disease (COPD) or heart disease

          -  Sleep apnea or active brain metastases with increased cranial pressure
Clinical trial NCT00309699 (phase 3, status: completed)
Conditions: bipolar disorder, mood disorders
ICD codes: F31.81, F31.89, F31.9, F25.0, F31.0, F31.31, F31.32, F34.81, F39, F34.9, F43.21, F10.14, F10.24, F11.14
Drugs: placebo, quetiapine, paliperidone er
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12, 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 3 years before the screening phase

          -  total score of at least 20 on the YMRS at screening and at baseline

          -  if taking mood stabilizers, antipsychotics, or antimanic drugs, must have discontinued
             that medication at least 3 days before baseline

          -  women must be postmenopausal (no spontaneous menses for at least 2 years), surgically
             sterile, abstinent, or agree to practice an effective method of birth control if they
             are sexually active before entry and throughout the study (effective methods of birth
             control include prescription hormonal contraceptives, intrauterine devices,
             double-barrier method, and male partner sterilization)

          -  able and willing to comply with self-administration of medication, or have consistent
             help or support available.

        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 NCT00673478 (phase 3, status: completed)
Conditions: pulmonary disease, chronic obstructive
ICD codes: J44.9, J44.1, J44.0
Drugs: tiotropium+salmeterol, salmeterol, tiotropium
SMILES: OCC1=C(O)C=CC(=C1)C(O)CNCCCCCCOCCCCC1=CC=CC=C1, OCC1=C(O)C=CC(=C1)C(O)CNCCCCCCOCCCCC1=CC=CC=C1, [H][C@]12O[C@@]1([H])[C@]1([H])C[C@@]([H])(C[C@@]2([H])[N+]1(C)C)OC(=O)C(O)(C1=CC=CS1)C1=CC=CS1
Eligibility criteria:

        Inclusion Criteria:

        COPD patients of >= 40 years old with moderate to severe COPD who are current or ex-smokers
        with a smoking history of at least 10 pack-years

        Exclusion Criteria:

          1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or
             hospitalisation for cardiac failure

          2. History of asthma

          3. Malignancy requiring treatment within past 5 years

          4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident
             bronchiectasis

          5. Known active tuberculosis

          6. Pregnant or nusing women

          7. Known hypersensitivity to components of the study medication
Clinical trial NCT00406653 (phase 3, status: terminated)
Conditions: crohn's disease
ICD codes: K50.90, K50.913, K50.914, K50.911, K50.912, K50.918, K50.919
Drugs: abatacept, placebo, abatacept
SMILES: [H][C@@]12CCCN1C(=O)[C@H](CC1=CC=CC=C1)N1C(=O)[C@](C)(NC(=O)[C@H]3CN(C)[C@]4([H])CC5=CNC6=CC=CC(=C56)[C@@]4([H])C3)O[C@@]21O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][C@@]12CCCN1C(=O)[C@H](CC1=CC=CC=C1)N1C(=O)[C@](C)(NC(=O)[C@H]3CN(C)[C@]4([H])CC5=CNC6=CC=CC(=C56)[C@@]4([H])C3)O[C@@]21O
Reason stopped: 
    sponsor decision
  
Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  have had Crohn's Disease for at least 3 months

          -  moderate to severely active Crohn's Disease

          -  have had an inadequate response or intolerance to other Crohn's Disease treatments
Clinical trial NCT00314249 (phase 3, status: completed)
Conditions: fibromyalgia
ICD codes: M79.7
Drugs: placebo, milnacipran 100mg
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CCN(CC)C(=O)C1(CC1CN)C1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR)
             Criteria

        Exclusion Criteria:

          -  psychiatric illness,

          -  depression,

          -  suicidal risk,

          -  substance abuse,

          -  pulmonary dysfunction,

          -  renal impairment,

          -  active cardiac disease,

          -  liver disease,

          -  autoimmune disease,

          -  cancer,

          -  inflammatory bowel disease
Clinical trial NCT01009593 (phase 3, status: terminated)
Conditions: hepatocellular carcinoma non-resectable, hepatocellular carcinoma recurrent, carcinoma, hepatocellular, liver diseases, neoplasms by histologic type, digestive system neoplasms, carcinoma, liver neoplasms, neoplasms, neoplasms by site, digestive system diseases, adenocarcinoma, neoplasms, glandular and epithelial
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8, K76.9, K71.8, K70.9, K71.9, K75.9, P78.84, Q44.6, D49.0, C26.9, D13.9, C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, D13.4, Z85.05, C22.8, C78.7, C22.9, D37.6, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, K92.9, B57.30, B57.39, K92.89, O99.611, O99.612, O99.613, C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: abt-869, sorafenib
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Reason stopped: 
    see termination reason in detailed description
  
Eligibility criteria:

        Inclusion Criteria

          -  Histologic or cytologic diagnosis with unresectable or metastatic HCC

          -  Child Pugh Class A

          -  ECOG performance status 0-1

          -  Adequate hematologic, hepatic, and renal function

        Exclusion Criteria

          -  Prior systemic (administered intravenously or orally rather than locoregionally)
             treatment for HCC

          -  Prior local therapy (including liver-directed therapy) within 4 weeks from entry

          -  Untreated brain or meningeal metastases

          -  Current treatment on another clinical trial

          -  Pregnancy or breastfeeding
Clinical trial NCT01861522 (phase 3, status: completed)
Conditions: perennial allergic rhinitis
ICD codes: D69.0, L50.0, B44.81, J30.89, J30.9, L20.84, H10.45
Drugs: bepotastine besilate, placebo
SMILES: OC(=O)CCCN1CCC(CC1)OC(C1=CC=C(Cl)C=C1)C1=CC=CC=N1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged between 7 and 15 years

          -  Patients who have received a diagnosis of perennial allergic rhinitis according to the
             diagnostic criteria

          -  Patients with a mean rhinorrhea score and a mean sneezing score of at least 2 on the
             basis of symptoms recorded in the nasal allergy diary during the observation period
             etc.

        Exclusion Criteria:

          -  Patients with vasomotor rhinitis or eosinophilic rhinitis

          -  Patients who have concurrent nasal disease that may affect the efficacy of TAU-284

          -  Patients with a history of any of the nasal surgical procedures

          -  Patients who have a positive result for pollen antigens which are dispersed during the
             study period

          -  Patients who have a positive result for dog dander or cat dander antigen and have a
             chance to touch dogs or cats.

          -  Patients with current or previous history of drug allergy

          -  Patients who concurrently have renal function abnormalities that may cause safety
             problems etc.
Clinical trial NCT00296504 (phase 3, status: completed)
Conditions: infection, human immunodeficiency virus
ICD codes: Z21
Drugs: fosamprenavir (gw433908), ritonavir
SMILES: CC(C)CN(C[C@@H](OP(O)(O)=O)[C@H](CC1=CC=CC=C1)NC(=O)O[C@H]1CCOC1)S(=O)(=O)C1=CC=C(N)C=C1, CC(C)[C@H](N1CCCNC1=O)C(=O)N[C@H](C[C@H](O)[C@H](CC1=CC=CC=C1)NC(=O)COC1=C(C)C=CC=C1C)CC1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant/non-lactating females >/=13 years of age (or >/= 18 years of age
             according to local requirements).

          -  Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or
             PRO30017 or have participated in APV30001 or other studies as deemed appropriate by
             the project team.

        Exclusion Criteria:

          -  Permanent discontinuation of GW433908 in a previous study due to intolerance.

          -  An active CDC Class C Event.

          -  Any condition which, in the opinion of the investigator, would preclude a subject from
             participation.
Clinical trial NCT00248157 (phase 3, status: terminated)
Conditions: diabetic retinopathy
ICD codes: H35.23, H35.20, H35.21, H35.22, E10.3553, E11.3553, E13.3553
Drugs: octreotide acetate in microspheres
SMILES: [H][C@]1(NC(=O)[C@H](CCCCN)NC(=O)[C@@H](CC2=CNC3=C2C=CC=C3)NC(=O)[C@H](CC2=CC=CC=C2)NC(=O)[C@H](CSSC[C@H](NC1=O)C(=O)N[C@H](CO)[C@@H](C)O)NC(=O)[C@H](N)CC1=CC=CC=C1)[C@@H](C)O
Reason stopped: 
    inconsistent treatment benefit
  
Eligibility criteria:

        Inclusion Criteria:

          -  written informed consent provided prior to participation in the extension study

          -  successful completion of study CSMS995 0804

          -  willingness to comply with all study requirements

        Exclusion Criteria:

          -  more than 8 weeks interval since the completion of study CSMS995 0804

          -  premature discontinuation from study CSMS995 0804

        Other protocol-defined inclusion/exclusion criteria may apply.
Clinical trial NCT00350779 (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: sitagliptin, comparator: placebo, rosiglitazone, metformin, glipizide
SMILES: N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F, CN(C)C(=N)NC(N)=N, CCN1C=C(C(O)=O)C(=O)C2=C1C=C(C=C2)C1=CC=NC=C1, CSCC[C@H](N)C(O)=O, CC1=NC=C(N=C1)C(=O)NCCC1=CC=C(C=C1)S(=O)(=O)NC(=O)NC1CCCCC1
Eligibility criteria:

        Inclusion Criteria:

          -  Patient has type 2 diabetes mellitus

          -  Patient is inadequately controlled while taking two oral antidiabetic medications

        Exclusion Criteria:

          -  Patient has a history of type 1 diabetes mellitus or history of ketoacidosis

          -  Patient required insulin therapy within the prior 3 months

          -  Patient has been taking Byetta (R) (exenatide) within the prior 3 months
Clinical trial NCT00493896 (phase 3, status: terminated)
Conditions: venous thromboembolism
ICD codes: O88.22, O88.23, O88.211, O88.212, O88.213, O88.219
Drugs: fondaparinux, enoxaparin
SMILES: CO[C@H]1O[C@H](COS(O)(=O)=O)[C@@H](O[C@@H]2O[C@H]([C@@H](O[C@H]3O[C@H](COS(O)(=O)=O)[C@@H](O[C@@H]4O[C@@H]([C@@H](O[C@H]5O[C@H](COS(O)(=O)=O)[C@@H](O)[C@H](O)[C@H]5NS(O)(=O)=O)[C@H](O)[C@H]4O)C(O)=O)[C@H](OS(O)(=O)=O)[C@H]3NS(O)(=O)=O)[C@H](O)[C@H]2OS(O)(=O)=O)C(O)=O)[C@H](O)[C@H]1NS(O)(=O)=O, [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Reason stopped: 
    low enrollment
  
Eligibility criteria:

        Inclusion Criteria:

          1. Ability or legally authorized representative (LAR) to provide informed consent

          2. Adult who has not had surgery within 10 days, admitted to the Sentara Norfolk General
             Hospital ICU Medical Teaching Services for any reason.

        Exclusion Criteria:

          1. Active or suspected bleeding

          2. Platelet count less than 100,000 per microliter (mm3) of blood

          3. Thrombolytic or anticoagulant treatment (including any doses of prophylactic UFH, LMWH
             or fondaparinux) during the current hospitalization

          4. Initial estimated CLcr < 30 ml/min as determined by the Cockcroft-Gault equation

          5. Initial labs indicative or suggestive of rapidly rising serum Creatinine (>1
             mg/dL/day)

          6. Pregnancy (for medicolegal considerations)

          7. Patients with or expecting to require an epidural catheter

          8. Patients who are expected to have an immediate (within 24h) need for surgery
Clinical trial NCT01248780 (phase 3, status: completed)
Conditions: rheumatoid arthritis
ICD codes: M06.9, M05.9, M06.08, M06.00, M06.011, M06.012, M06.019
Drugs: golimumab, placebo, methotrexate (mtx)
SMILES: 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:

        - Diagnosis of rheumatoid arthritis for at least 6 months

          -  Be on a stable dose of methotrexate for 4 weeks

          -  Have at least 4 swollen and 4 tender joints

        Exclusion Criteria:

          -  Prior exposure to biologic anti-TNFalpha agents

          -  Inflammatory diseases other than rheumatoid arthritis

          -  Treatment with Disease Modifying Anti-rheumatic drug (DMARDs)/systemic
             immunosuppressives other than methotrexate during the 4 weeks prior to the first
             administration of study agent

          -  History of, or ongoing, chronic or recurrent infectious disease
Clinical trial NCT00552097 (phase 3, status: completed)
Conditions: atherosclerosis, hypercholesterolemia, hyperlipoproteinemia type ii
ICD codes: I67.2, I70.90, I70.91, I70.0, I70.1, I70.8, I25.83, E78.01, E78.00, Z83.42
Drugs: ezetimibe (plus simvastatin), placebo (plus simvastatin)
SMILES: O[C@@H](CC[C@@H]1[C@H](N(C1=O)C1=CC=C(F)C=C1)C1=CC=C(O)C=C1)C1=CC=C(F)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Genotype-confirmed heterozygous familial hypercholesterolemia with written
             documentation of the genetic diagnosis at the time of screening and LDL-C >=210 mg/dL
             (5.43 mmol/L), or clinical diagnosis of heterozygous familial hypercholesterolemia,
             defined as LDL-C >=210 mg/dL (5.43 mmol/L) and at least one of the following:

               -  tendinous xanthoma

               -  child <18 years of age with hypercholesterolemia (LDL-C >159 mg/dL (4.11 mmol/L)

               -  has a sibling with hypercholesterolemia (LDL-C >190 mg/dL [4.91 mmol/L]) and
                  tendinous xanthoma

               -  family history with an LDL-C value distribution pattern compatible with dominant
                  autosomal transmission and at least one relative presenting fasting total
                  cholesterol values >348 mg/dL (9.0 mmol/L) after exclusion of secondary causes of
                  dyslipidemia

          -  LDL-C >=210 mg/dL (5.43 mmol/L) 1 week before randomization

          -  plasma triglyceride level <=400 mg/dL (4.52 mmol/L)

        Exclusion Criteria:

          -  pregnancy or any other situation, condition, or illness that, in the opinion of the
             investigator, may interfere with optimal participation in the study

          -  presence of an apolipoprotein B gene mutation with confirmed absence of an LDL
             receptor mutation in either allele

          -  undergoing LDL-apheresis or plasma apheresis

          -  unsuitable plaque or artery morphology

          -  use of certain drugs, foods, or other agents known to alter cholesterol levels or to
             cause pharmacokinetic interactions with either ezetimibe or simvastatin