araag2/HINT huggingface dataset:
Clinical trial NCT00300781 (phase 2, status: completed)
Conditions: breast neoplasms, neoplasms
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: neratinib
SMILES: CCOC1=C(NC(=O)\C=C\CN(C)C)C=C2C(NC3=CC=C(OCC4=CC=CC=N4)C(Cl)=C3)=C(C=NC2=C1)C#N
Eligibility criteria:

        Inclusion Criteria:

          -  Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV

          -  Progression following at least 6 weeks of standard doses of Herceptin (Arm A only)

          -  Over-expression of HER2

          -  Tumor tissue available and adequate for analysis at screening

          -  At least one measurable lesion

        Exclusion Criteria:

          -  Prior treatment with Herceptin (Arm B only)

          -  More than 4 prior cytotoxic chemotherapy regimens

          -  Subjects with bone or skin as the only site of measurable disease

          -  Inadequate cardiac function

          -  Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer
             therapy within 1 week of treatment day 1

          -  Active central nervous system metastases

          -  Pregnant or breastfeeding women

          -  Inability to swallow the HKI-272 capsules
Clinical trial NCT00376948 (phase 2, status: completed)
Conditions: pancreatic cancer
ICD codes: C25.3
Drugs: erlotinib hydrochloride, gemcitabine hydrochloride
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed pancreatic adenocarcinoma

               -  Locally advanced or metastatic disease by radiological evidence

          -  Must have biopsy material consisting of 10 unstained slides or paraffin-embedded
             tissue blocks available for correlative studies

          -  No endocrine tumor or lymphoma of the pancreas

          -  No history of CNS (central nervous system) metastases

        PATIENT CHARACTERISTICS:

          -  SWOG (Southwest Oncology Group) performance status 0-1

          -  Life expectancy ≥ 12 weeks

          -  Platelet count ≥ 100,000/mm^3

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Bilirubin < 2.0 mg/dL

          -  AST (aspartate aminotransferase) and ALT (alanine aminotransferase) < 1.5 times upper
             limit of normal

          -  Creatinine < 1.5 mg/dL

          -  Albumin > 2.5 g/dL

          -  INR (international normalized ratio) < 1.3 (in the absence of ongoing treatment with
             warfarin)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No active infection

          -  No condition that would limit the ability to receive oral medications

          -  No requirement for a gastrostomy tube for the administration of drugs

          -  No serious concurrent systemic disorder, that, in the opinion of the investigator, is
             incompatible with the study

          -  No active second primary malignancy within the past year except in situ carcinoma of
             the cervix or adequately treated basal cell carcinoma of the skin

          -  No allergy to any study drug

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy or radiotherapy for metastatic disease

               -  Prior adjuvant chemotherapy allowed provided it was completed at least 6 months
                  ago

          -  No prior gemcitabine hydrochloride or epidermal growth factor receptor-inhibiting
             agents

          -  No other concurrent chemotherapy, immunotherapy, tumor-directed hormonal therapy, or
             radiotherapy

          -  No other concurrent investigational agents

          -  No other concurrent antitumor therapy
Clinical trial NCT00285402 (phase 2, status: unknown status)
Conditions: migraine, migraine headache, migraine disorders, migraine with aura, migraine without aura
ICD codes: G43.B1, G43.D1, G43.B0, G43.D0, G43.A1, G43.411, G43.419, G43.B1, G43.D1, G43.B0, G43.D0, G43.A1, G43.411, G43.419, G43.B1, G43.D1, G43.B0, G43.D0, G43.A1, G43.411, G43.419, G43.111, G43.011, G43.119, G43.101, G43.001, G43.109, G43.711
Drugs: ast-726 low dose, ast-726 high dose, ast-726 placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Primary Inclusion Criteria:

          1. Has migraine headaches with or without aura according to International Headache
             Society guidelines (Committee, 2004).

          2. Has had migraines for at least 6 months prior to study enrollment period.

          3. Migraines began before age 50.

          4. Has 2 to 10 attacks per month and greater than or equal to 3 migraine days per month
             in the last 3 months prior to study enrollment.

          5. Has 2 to 10 attacks in 30 days during the Baseline Period.

        Additional inclusion criteria in protocol

        Primary Exclusion Criteria:

          1. Has headache equal to or greater than 18 days per month.

          2. Has used migraine medications (e.g., topiramate, beta-blockers) for prophylactic use
             within 60 days prior to study enrollment.

          3. Has excessive use of acute migraine medications (e.g., triptans, dihydroergotamine
             [DHE]) greater than 15 days per month.

          4. Has taken nitroglycerine-containing medications within 60 days prior to study
             enrollment.

          5. Failed more than 3 clinical studies of effective migraine prevention medications due
             to uncontrolled migraines.

        Additional exclusion criteria in protocol
Clinical trial NCT00300443 (phase 2/phase 3, status: completed)
Conditions: ocular hypertension
ICD codes: H40.053, H40.051, H40.052, H40.059
Drugs: bimatoprost
SMILES: CCNC(=O)CCC\C=C/C[C@H]1[C@@H](O)C[C@@H](O)[C@@H]1\C=C\[C@@H](O)CCC1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of glaucoma or ocular hypertension in both eyes

          -  Patient requires IOP-lowering drug in both eyes

        Exclusion Criteria:

          -  Uncontrolled medical conditions

          -  Ocular seasonal allergies within the past 2 years
Clinical trial NCT01628692 (phase 2, status: completed)
Conditions: hepatitis c virus
ICD codes: B00.81, B25.1, B26.81, B58.1, K75.4, A51.45, B17.2
Drugs: daclatasvir, simeprevir, ribavirin
SMILES: COC(=O)N[C@@H](C(C)C)C(=O)N1CCC[C@H]1C1=NC=C(N1)C1=CC=C(C=C1)C1=CC=C(C=C1)C1=CN=C(N1)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)OC)C(C)C, [H]\C1=C([H])\[C@]2([H])C[C@]2(N=C(O)[C@]2([H])C[C@]([H])(C[C@@]2([H])C(=O)N(C)CCCC1)OC1=C2C=CC(OC)=C(C)C2=NC(=C1)C1=NC(=CS1)C(C)C)C(O)=NS(=O)(=O)C1CC1, NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O
Eligibility criteria:

        Key Inclusion Criteria:

          -  Hepatitis C virus (HCV) genotype 1a or 1b

          -  Males and females, ≥18 years of age

          -  HCV RNA ≥10,000 IU/mL

          -  Participants with compensated cirrhosis are permitted

               -  Advanced fibrosis (F3/F4) is capped at approximately 35% of the total treated
                  population with a minimum of 20% F4 patients

               -  If no cirrhosis, a liver biopsy within 3 years prior to enrollment

               -  If cirrhosis is present, any prior liver biopsy

        Key Exclusion Criteria:

          -  Liver or any other transplant (other than cornea and hair)

          -  Evidence of a medical condition contributing to chronic liver disease other than HCV
             infection

          -  Current or known history of cancer, (except in situ carcinoma of the cervix or
             adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior
             to enrollment

          -  Evidence of decompensated liver disease including, but not limited to, radiologic
             criteria, a history or presence of ascites, bleeding varices, or hepatic
             encephalopathy

          -  Patients infected with HIV or hepatitis B virus

          -  Gastrointestinal disease impacting absorption of study drug

          -  Uncontrolled diabetes or hypertension

          -  Prior exposure to an HCV direct-acting agent

          -  Any criteria that would exclude the patient from receiving ribavirin

          -  Absolute neutrophil count <1.5*1,000,000,000 cells/L (<1.2*1,000,000,000 cells/L for
             Black/African Americans)

          -  Platelets <90*1,000,000,000 cells/L

          -  Hemoglobin <12 g/dL for females, <13 g/dL for males

          -  Alanine aminotransferase ≥5*upper limit of normal

          -  In patients without cirrhosis, total bilirubin ≥2 mg/dL unless patient has a
             documented history of Gilbert's disease

          -  In patients with cirrhosis, total bilirubin o ≥1.5 mg/dL

          -  International normalized ratio ≥1.7

          -  QTcF or QTcB >500 mSec

          -  Creatinine clearance ≤50 mL/min

          -  Alpha fetoprotein (AFP) >100 ng/mL OR

          -  AFP ≥50 ng/mL and ≤100 ng/mL requiring liver ultrasound

          -  Albumin <3.5 g/dL
Clinical trial NCT00465244 (phase 2/phase 3, status: withdrawn)
Conditions: seizures
ICD codes: G40.89, R56.1, F44.5, G40.501, G40.509, G40.111, G40.119
Drugs: levetiracetam 1 g iv + lorazepam 2 mg iv, placebo + lorazepam 3 mg iv
SMILES: CC(C)CC1=CC=C(C=C1)C(C)C(O)=O, OC1N=C(C2=CC=CC=C2Cl)C2=C(NC1=O)C=CC(Cl)=C2
Reason stopped: 
    inability to recruit subjects
  
Eligibility criteria:

        Inclusion Criteria:

          -  seizure

        Exclusion Criteria:

          -  pregnancy

          -  renal failure

          -  hepatic impairment
Clinical trial NCT00003298 (phase 2, status: completed)
Conditions: gastric cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: cisplatin, fluorouracil, leucovorin calcium, paclitaxel
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, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction

          -  Localized cancer that is potentially curable by surgery (T2, N1-2, M0 or T3-4, any N,
             M0)

          -  No metastatic cancer to the ovaries

          -  Age: 18 and over

          -  Easter Cooperative Oncology Group (ECOG) performance status 0-2

          -  White blood cell (WBC) count at least 4,000 cells/mm3

          -  Platelet count at least 150,000/mm3

          -  Bilirubin less than 2 mg/dL

          -  Creatinine no greater than 1.5 mg/dL

          -  Creatinine clearance greater than 50 mL/min

          -  Caloric intake must be at least 1500 kcal/day

          -  No prior history of cancer within the past 5 years except for basal cell carcinoma of
             the skin or in situ carcinoma of the cervix

          -  No prior radiation therapy, except for skin cancer

          -  Fertile patients must use adequate contraception

          -  Met criteria for re-registration after surgery

               -  T1N1-2M0, T2N1-2M0 or T3-4NanyM0 at time of initial re-registration.

               -  No evidence of metastatic disease from postoperative pathologic staging.

               -  ECOG performance status of 0, 1, or 2 at re-registration

               -  Curative resection performed

               -  Re-registered 4 - 6 weeks from the date of surgery

               -  WBC ≥ 4000 cells/mm³, platelets ≥ 150,000/mm³, creatinine ≤ 1.5 mg/dl or
                  creatinine clearance of > 50 ml/min (measured or calculated) and total serum
                  bilirubin < 2 mg/dl, all within four weeks prior to re-registration

        Exclusion Criteria:

          -  Prior chemotherapy

          -  Clinically significant auditory impairment

          -  Significant heart disease

          -  Pregnant or lactating
Clinical trial NCT01192503 (phase 2/phase 3, status: terminated)
Conditions: restless legs syndrome
ICD codes: G25.81
Drugs: rasagiline, placebo (sugar pill)
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
Reason stopped: 
    slow enrollment
  
Eligibility criteria:

        Inclusion Criteria:

          -  Men and women at least 18 years of age, capable of providing informed consent

          -  Diagnosed with idiopathic RLS, defined as meeting the International RLS Study Group
             diagnostic criteria without evidence for secondary causes of RLS

          -  Moderate or severe symptoms, defined as a score of 15 or greater on the International
             RLS Study Group Rating Scale (IRLS)

          -  Not currently receiving treatment for RLS. A 30-day washout period will be required
             for participants on dopamine agonists or other therapies. Stable doses of iron
             supplementation will be allowed

          -  On a stable dose of the following antidepressants, for at least 30 days prior to
             baseline visit:

               -  Amitriptyline, up to 50mg/day

               -  Trazodone, up to 100mg/day

               -  Citalopram, up to 20mg/day

               -  Escitalopram, up to 10mg/day

               -  Paroxetine, up to 30mg/day

               -  Sertraline, up to 100mg/day

          -  Female subjects must not be of childbearing potential or must agree to use of
             contraception for duration of study

        Exclusion Criteria:

          -  Signs consistent with a secondary cause of RLS:

          -  History of initial unresponsiveness to dopaminergic RLS treatment despite adequate
             dose of initial therapy

          -  Use of another MAO inhibitor within 30 days of baseline visit

          -  Allergy or adverse reaction to rasagiline

          -  Prior adverse reaction to tyramine-containing foods

          -  Use of meperidine or other opiates within 30 days of the baseline visit

          -  Use of benzodiazepines within 30 days of the baseline visit

          -  Use of antidepressants, including TCAs, SSRIs, and SNRIs, except for those permitted
             as listed above

          -  Use of other drugs or supplements contraindicated with rasagiline, including St.
             John's wort, mirtazapine, cyclobenzaprine, dextromethorphan, cold products that
             contain ephedrine, pseudoephedrine

          -  Scheduled to undergo elective surgery during the course of the study

          -  Active medical or psychiatric illness that requires changes to treatment during the
             course of the study or jeopardize the subject's ability to remain in the study
Clinical trial NCT01061736 (phase 2/phase 3, status: completed)
Conditions: rheumatoid arthritis
ICD codes: M06.9, M05.9, M06.08, M06.00, M06.011, M06.012, M06.019
Drugs: sarilumab, placebo (for sarilumab), methotrexate, folic acid
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, NC1=NC(=O)C2=NC(CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)=CN=C2N1
Eligibility criteria:

        Inclusion criteria :

          -  Diagnosis of rheumatoid arthritis ≥3 months duration

          -  Active disease defined as:

               -  at least 8/68 tender joints and 6/66 swollen joints,

               -  high sensitivity C-reactive protein (hs-CRP) >6 mg/l,

               -  continuous treatment with MTX for at least 12 weeks prior to baseline visit and
                  on stable dose for at least 6 weeks prior to screening visit.

        Part B only:

          -  Bone erosion based on documented X-ray prior to first study drug intake, or

          -  Cyclic Citrullinated Peptide (CCP) positive, or

          -  Rheumatoid Factor (RF) positive.

        Exclusion criteria:

          -  Age <18 years or >75 years.

          -  Treatment with disease-modifying antirheumatic drugs (DMARDs) other than MTX within 4
             weeks or 12 weeks prior to screening (depending on DMARDs).

          -  Past history of non-response to prior Tumor Necrosis Factor (TNF) or biologic
             treatment.

          -  Any past or current biologic agents for the treatment of rheumatoid arthritis within 3
             months.

          -  Use of parenteral glucocorticoids or intraarticular glucocorticoids within 4 weeks
             prior to screening visit.

          -  Use of oral glucocorticoid greater than 10mg/day or equivalent/day, or a change in
             dosage within 4 weeks prior to baseline visit.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Clinical trial NCT00448058 (phase 2, status: completed)
Conditions: depressive disorder
ICD codes: F25.1, F33.0, F33.1, F33.9, F32.0, F32.1, F32.9
Drugs: gsk372475, venlafaxine, placebo
SMILES: COC[C@H]1[C@H]2CC[C@@H](C[C@@H]1C1=CC=C(Cl)C(Cl)=C1)N2C, [O-][N+](=O)C1=CC2=C(NC(=O)CN=C2C2=CC=CC=C2Cl)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:

          -  Major depressive episode (MDE) associated with Major Depressive Disorder (DSM-IV-TR
             criteria)

          -  Duration of current episode is at least 12 weeks duration and less than 2 years

          -  Symptoms of decreased energy, pleasure, and interest

          -  Female subjects who agree to use acceptable methods of birth control throughout the
             study

        Exclusion criteria:

          -  Current diagnosis of Panic Disorder, or symptoms of generalized anxiety or panic
             attacks that could interfere with their ability to complete the trial

          -  Symptoms of MDE better accounted for by another diagnosis

          -  Diagnosis of Bipolar, schizophrenia, other psychotic disorder(s), borderline or
             antisocial personality disorder, or dementia.

          -  Started psychotherapy within 3 months prior to the Screening

          -  Received electroconvulsive therapy or transcranial magnetic stimulation within 6
             months prior to screening

          -  Received psychoactive drugs within 4 weeks of randomization

          -  Positive urine drug screen or positive blood alcohol

          -  Suicidal risk or has had any previous suicide attempt, a family history of suicide
             attempt

          -  Positive pregnancy test

          -  History of seizure disorder, myocardial infarction (< 1yr), or unstable medical
             condition

          -  Failed to respond to an adequate course of pharmacotherapy of at least 2 different
             antidepressants
Clinical trial NCT01656031 (phase 2, status: completed)
Conditions: leukemia
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: clofarabine, cytarabine
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Pathologic confirmation of acute myeloid leukemia (AML) or acute lymphoblastic
             leukemia (ALL)

               -  No M3 AML

          -  Meets 1 of the following criteria:

               -  In first relapse

               -  In second relapse after a second complete remission (CR) that lasted ≥ 3 months

               -  Refractory to initial induction therapy

          -  No symptomatic CNS involvement

        PATIENT CHARACTERISTICS:

          -  ECOG performance status ≤ 2

          -  Creatinine < 2 mg/dL

          -  Bilirubin ≤ 2 mg/dL

          -  AST and ALT ≤ 4 times upper limit of normal

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 2 weeks after
             completing study treatment

          -  Ejection fraction ≥ 45% by echocardiogram

          -  No active, uncontrolled systemic infection considered opportunistic, life-threatening,
             or clinically significant

          -  No psychiatric disorders that would interfere with giving consent, study
             participation, or follow-up procedures

          -  No other severe concurrent disease that would preclude study treatment

        PRIOR CONCURRENT THERAPY:

          -  At least 1 week since prior therapy and recovered

          -  No other concurrent chemotherapy

               -  Hydroxyurea to control WBC count before starting study treatment allowed

          -  No concurrent corticosteroids unless used for diseases other than leukemia

          -  No concurrent palliative radiotherapy

          -  No concurrent growth factors (e.g., epoetin alfa, filgrastim [G-CSF], or sargramostim
             [GM-CSF]) in patients with AML
Clinical trial NCT01258803 (phase 2, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: formoterol fumarate dpi, mometasone furoate/formoterol fumarate mdi (ex-actuator) without spacer, mometasone furoate/formoterol fumarate mdi (ex-actuator) with spacer, placebo mdi with spacer, placebo mdi without spacer, mometasone furoate dpi
SMILES: COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1, [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=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, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
Eligibility criteria:

        Inclusion Criteria:

          -  Must have a diagnosis of asthma of at least 6 months duration

          -  Must have taken an Inhaled Corticosteroid ([ICS]; alone or in combination with a
             long-acting beta-2 Agonist [LABA]) for at least 3 months prior to the Screening Visit
             and must have been on a stable daily dose for at least 2 weeks prior to the Screening
             Visit

          -  FEV1 must be at least 70% predicted after all restricted medications have been
             withheld for the appropriate intervals

          -  Must demonstrate an increase in absolute FEV1 of at least 12% within 30 minutes after
             administration of 360 mcg albuterol (4 inhalations x 90 mcg, ex-actuator) or of
             nebulized albuterol (2.5 mg), if confirmed as standard office practice

        Exclusion Criteria:

          -  Has been treated in the emergency room for a severe asthma exacerbation requiring
             systemic glucocorticosteroid treatment, or hospitalized for management of airway
             obstruction within 3 months prior to the Screening Visit

          -  Has required ventilator support for respiratory failure secondary to asthma

          -  Demonstrates a decrease in absolute FEV1 of >20% at any time from the Screening Visit
             up to and including the Baseline Visit

          -  Requires the use of greater than 8 inhalations per day of short-acting beta-2 agonists
             (SABA) MDI, or 2 or more nebulized treatments per day of 2.5 mg SABA on any 2
             consecutive days from the Screening Visit up to and including the Baseline Visit

          -  Experiences a clinical deterioration in asthma that results in emergency treatment,
             hospitalization due to asthma, or treatment with additional, excluded asthma
             medication (including oral or other systemic corticosteroids, but allowing SABA) as
             judged by the investigator, at any time from the Screening Visit up to and including
             the Baseline Visit