araag2/HINT huggingface dataset:
Clinical trial NCT00038766 (phase 2, status: terminated)
Conditions: crohn disease
ICD codes: K50.90, K50.913, K50.914, K50.911, K50.912, K50.918, K50.919
Drugs: semapimod, semapimod, placebo
SMILES: C\C(=N/NC(N)=N)C1=CC(=CC(NC(=O)CCCCCCCCC(=O)NC2=CC(=CC(=C2)C(\C)=N\NC(N)=N)C(\C)=N\NC(N)=N)=C1)C(\C)=N\NC(N)=N, C\C(=N/NC(N)=N)C1=CC(=CC(NC(=O)CCCCCCCCC(=O)NC2=CC(=CC(=C2)C(\C)=N\NC(N)=N)C(\C)=N\NC(N)=N)=C1)C(\C)=N\NC(N)=N, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    unable to enroll into study.
  
Eligibility criteria:

        Inclusion Criteria

          -  Baseline Crohn's Disease Activity Index (CDAI) 250-400, inclusive

          -  Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis,
             confirmed by radiography and/or endoscopy

          -  Patients receiving medications for CD must be on stable doses entering the study

          -  Any CD medication which has been discontinued must have been discontinued at least 4
             weeks prior to screening, with the exception of infliximab, which must have been
             discontinued at least 8 weeks prior to screening

        Exclusion Criteria

          -  Patients with any ostomy or extensive bowel resection

          -  Current evidence of bowel obstruction or history within the preceding six months as
             confirmed by radiography, endoscopy, or surgery

          -  Patients with stool examination positive for enteric pathogens, pathogenic ova or
             parasites, or Clostridium difficile toxin

          -  Treatment with any other experimental therapeutics within the last 4 weeks before
             enrollment
Clinical trial NCT01128569 (phase 2, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: fluticasone furoate, ff/vilanterol (vi; gw642444m), placebo
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, OCC1=C(O)C=CC(=C1)[C@@H](O)CNCCCCCCOCCOCC1=C(Cl)C=CC=C1Cl, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).

          -  Females of non-child bearing potential.

          -  Documented history of bronchial asthma, first diagnosed at least 6 months prior to the
             screening visit and currently being treated only with intermittent short-acting beta
             -agonist therapy by inhalation

          -  Pre-bronchodilator FEV1 >70% of predicted at screening

          -  Subjects who are current non-smokers

          -  Methacholine challenge PC20 < 8 mg/mL at screening

          -  Screening allergen challenge demonstrates that the subject experiences an early
             asthmatic response

        Exclusion Criteria:

          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities

          -  Subject is hypertensive at screening

          -  Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the
             first dose of study medication.

          -  History of life-threatening asthma

          -  Symptomatic with hay fever at screening or predicted to have symptomatic hayfever

          -  Unable to abstain from short acting beta agonists

          -  Unable to abstain from antihistamines

          -  Unable to abstain from other medications including non-steroidal anti-inflammatory
             drugs (NSAIDs), anti-depressant drugs, anti-asthma anti-rhinitis or hay fever
             medication

          -  The subject has participated in a study with a new molecular entity during the
             previous 3 months or has participated in 4 or more clinical studies in the previous 12
             months

          -  undergoing allergen desensitisation therapy
Clinical trial NCT00583947 (phase 2, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: arformoterol, levalbuterol
SMILES: COC1=CC=C(C[C@@H](C)NC[C@H](O)C2=CC(NC=O)=C(O)C=C2)C=C1, [H][C@]12CC[C@]([H])(C[C@@H](C1)OC(=O)C(CO)C1=CC=CC=C1)[N+]2(C)C(C)C
Eligibility criteria:

        Inclusion Criteria:

          -  Male and Female

          -  Between Age 2 and 11, inclusive, at the time of consent

          -  Weight equal to or greater than 15 Kg

          -  History of physician-diagnosed asthma of at least 2 years duration for children age 6
             and older, and at least 1 year duration for children 5 and younger.

        Exclusion Criteria:

          -  Female subject who is pregnant or lactating.

          -  Subject who has a history of hospitalization for asthma within one year, or who is
             scheduled for in-patient hospitalization, including elective surgery during the course
             of the trial.

          -  Subject with any history of life-threatening asthma defined as a history of asthma
             episodes requiring intubation, associated with hypercapnia, respiratory arrest, or
             hypoxic seizures.

          -  Subject with a history of cancer.

          -  Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure
             disorders.

          -  Subject with a history of cigarette smoking or use of any tobacco products.
Clinical trial NCT00391638 (phase 2/phase 3, status: completed)
Conditions: hepatitis b, hiv infections
ICD codes: B18.0, B18.1, B19.10, B19.11, B17.0, B16.0, B16.1, Z21
Drugs: truvada (emtricitabine + tenofovir df)
SMILES: [H][C@@](C)(CN1C=NC2=C(N)N=CN=C12)OCP(=O)(OCOC(=O)OC(C)C)OCOC(=O)OC(C)C
Eligibility criteria:

        Inclusion Criteria:

          -  HIV infection

          -  Karnofsky above 80 per cent

          -  Stable ARV since 4 months

          -  CD4 above 200 per mm3

          -  ARN VIH below 10000 copies per ml

          -  hepatitis B chronic with : positive antigenaemia HBe and negative antiHBe, positive
             DNA HBV before or under tenofovir treatment, DNA HBV negative or below 10000 copies
             per ml at W-8.

          -  Previous treatment by tenofovir and lamivudine or emtricitabine more than 6 months

        Exclusion Criteria:

          -  HIV 2 infection

          -  Hepatitis C or D

          -  Opportunistic infection

          -  Alcool consummation more than 50g/d

          -  Cirrhosis

          -  Pregnancy or plan of pregnancy

          -  Breastfeeding

          -  Immunosuppressive or modulating of the immune response treatment

          -  Other Hepatitis B treatments than tenofovir, lamivudine or emtricitabine since 6
             months

          -  Malabsorption

          -  Exclusive HIV therapy with Truvada

          -  Evolutive cancer under chemotherapy
Clinical trial NCT00108953 (phase 2, status: completed)
Conditions: carcinoma, hepatocellular
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: sorafenib (nexavar, bay43-9006) plus doxorubicin, doxorubicin/placebo
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O
Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have a life expectancy of at least 12 weeks

          -  Patients with advanced HCC (unresectable, and/or metastatic) which has been
             histologically or cytologically documented

          -  Patients must have at least one tumor lesion that meets both of the following
             criteria:

               -  can be accurately measured in at least one dimension according to Response
                  Evaluation Criteria in Solid Tumors (RECIST)

               -  has not been previously treated with local therapy

          -  Patients who have received local therapy except chemoembolization, such as surgery,
             radiation therapy, hepatic arterial embolization, radiofrequency ablation,
             percutaneous ethanol injection or cryoablation are eligible, provided that they either
             have a target lesion which has not been subjected to local therapy and/or the target
             lesion(s) within the field of the local therapy has shown an increase of 25% in the
             size. Local therapy must be completed at least 4 weeks prior to the baseline scan

          -  Patients who have an Eastern Cooperative Oncology Group (ECOG) performance status of
             0, 1 or 2

        Exclusion Criteria:

          -  Previous or concurrent cancer that is distinct in primary site or histology from HCC,
             EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, and superficial
             bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry
             is permitted

          -  History of cardiac disease

          -  Serious myocardial dysfunction

          -  Active, clinically serious infections

          -  Known history of Human Immunodeficiency Virus (HIV) infection

          -  Known Central Nervous System (CNS) tumors including metastatic brain disease

          -  Patients with clinically significant gastrointestinal bleeding within 30 days prior to
             study entry
Clinical trial NCT00303615 (phase 2, status: terminated)
Conditions: metastatic breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: fluoxymesterone 10 mg, anastrozole 1 mg
SMILES: [H][C@@]12CC[C@](C)(O)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)CC[C@]12C, CC(C)(C#N)C1=CC(=CC(CN2C=NC=N2)=C1)C(C)(C)C#N
Reason stopped: 
    low accrural
  
Eligibility criteria:

        Inclusion Criteria:

          -  Over 18 years of age

          -  ER Negative and PR Negative

          -  Progression of disease in the metastatic setting despite taxane or other
             chemotherapeutic therapies including Herceptin (patients on Herceptin may continue
             this therapy while on study)

          -  Maximized chemotherapy in the metastatic setting or patient experienced side effects
             contributing to decreased quality of life and elects to defer chemotherapy

          -  Evaluable disease by either:

               -  CT Scan with or without contrast (lesions must be greater than 2 mm)

               -  PET Scan, or Bone Scan, or Plain skeletal films

               -  Chest wall or skin recurrence (digital photo to capture evaluable disease)

          -  Evaluable symptoms (pain, shortness of breath, fatigue, anorexia)

          -  Performance Status of 0, 1, or 2

          -  Bilateral mammogram performed within one year before registration

        Exclusion Criteria:

          -  Uncontrolled hypercalcemia greater than 11

          -  Uncontrolled congestive heart failure greater than 2 NYHA class

          -  Central Nervous System metastasis

          -  Concomitant steroid use

          -  Performance Status of greater than 2

          -  Bilirubin greater than 5.5
Clinical trial NCT00611884 (phase 2, status: completed)
Conditions: diabetes, diabetes mellitus, type 2
ICD codes: E23.2, N25.1, P70.2, O24.92, Z83.3, Z86.32, E10.65, E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: insulin glargine, insulin degludec, insulin degludec, insulin degludec, metformin
SMILES: [Na+].[Na+].[O-]P([O-])(F)=O, [Na+].[Na+].[O-]P([O-])(F)=O, [Na+].[Na+].[O-]P([O-])(F)=O, [Na+].[Na+].[O-]P([O-])(F)=O, CSCC[C@H](N)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before any trial-related activities. (Trial-related
             activities are any procedure that would not have been performed during normal
             management of the subject.)

          -  Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months
             (no previous insulin treatment or previous short term insulin treatment maximeum 14
             days within the last 3 months)

          -  Treatment with one or two oral anti-diabetic drug (OADs): metformin, sulphonylurea
             (SU) (or other insulin secretagogue e.g. repaglinide, nateglinide), alpha-glucosidase
             inhibitors for at least 2 months at a stable maximally tolerated dose or at least half
             maximally allowed dose according to the summary of product characteristics (SPC) or
             locally approved PI

          -  HbA1c 7.0-11.0 % (both inclusive)

          -  Body Mass Index (BMI) 23-42 kg/m^2 [lb/in^2 x 703] (both inclusive)

        Exclusion Criteria:

          -  Metformin contraindication according to local practice

          -  Thiazolidinedione (TZD) treatment within previous three months prior to visit 1

          -  Any systemic treatment with products which in the Investigator's opinion could
             interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) three
             months prior to randomisation

          -  Subject has a clinically significant, active (during the past 12 months) disease of
             the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system
             (except for conditions associated with type 2 diabetes) that, in the opinion of the
             Investigator, may confound the results of the trial or pose additional risk in
             administering trial drug
Clinical trial NCT00326092 (phase 2, status: completed)
Conditions: open-angle glaucoma, ocular hypertension
ICD codes: H40.10X0, H40.10X1, H40.10X2, H40.10X3, H40.10X4, H40.1130, H40.1131, H40.053, H40.051, H40.052, H40.059
Drugs: brinzolamide/timolol
SMILES: [H][C@](O)(CNC(C)(C)C)COC1=NSN=C1N1CCOCC1
Eligibility criteria:

        Inclusion Criteria:

          -  Adults of either sex and any race diagnosed with open-angle glaucoma (with or without
             pseudoexfoliation or pigment dispersion component)

        Exclusion Criteria:

          -  Under 18
Clinical trial NCT00655473 (phase 2, status: completed)
Conditions: coronary heart disease
ICD codes: I25.10, I25.110, I25.119, I25.111, I25.118
Drugs: dalcetrapib (ro4607381), placebo
SMILES: CCC(CC)CC1(CCCCC1)C(=O)NC1=CC=CC=C1SC(=O)C(C)C, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-75 years of age;

          -  CHD, including patients with other CHD risk factors;

          -  treated appropriately for dyslipidemia;

          -  clinically stable.

        Exclusion Criteria:

          -  previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or
             vaccine;

          -  recent (within 3 months) clinically significant coronary events, transient ischemic
             attacks or cerebrovascular accident;

          -  severe anemia;

          -  uncontrolled hypertension;

          -  poorly controlled diabetes.
Clinical trial NCT00420004 (phase 2, status: completed)
Conditions: major depressive disorder
ICD codes: F33.0, F33.1, F33.9, F32.0, F32.1, F32.9, F33.40
Drugs: ly2216684, placebo, escitalopram
SMILES: [H][C@]1(CNCCO1)[C@@](O)(CC1=C(OC)C=CC(F)=C1)C1CCOCC1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN(C)CCCC1(OCC2=C1C=CC(=C2)C#N)C1=CC=C(F)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Meet criteria for major depressive disorder (MDD) without psychotic features.

          -  Have education level and a degree of understanding such that the participant can
             communicate with the site study personnel.

          -  Judged to be reliable and agree to keep all appointments for clinic visits, tests, and
             procedures, including venipuncture, and examinations required by the protocol.

        Exclusion Criteria:

          -  Have had any additional, ongoing psychiatric condition other than major depression or
             dysthymia that was considered the primary diagnosis within 6 months of the first study
             visit.

          -  Have a lifetime history of Bipolar I or II Disorder, psychotic disorder, or a
             factitious disorder.

          -  Are judged to be at high risk for imminently harming themselves or others.

          -  Have a serious medical illness, including any cardiovascular, hepatic, respiratory,
             hematologic, endocrinologic, neurologic disease, or clinically significant laboratory
             or electrocardiogram (ECG) abnormality. Clinically significant lab abnormalities are
             those which, in the judgment of the investigator, indicate a serious medical problem
             or require intervention.

          -  Have any diagnosed medical condition which could be exacerbated by treatment with
             LY2216684, including hypertension, increased heart rate, arrhythmias, heart disease,
             narrow angle glaucoma, or urinary hesitancy.
Clinical trial NCT00210379 (phase 2, status: completed)
Conditions: lymphoma, b cell
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: rituximab, chop, intrathecal methotrexate
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1, 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:

          1. age = 18 years.

          2. ECOG performance status 0-2

          3. Histologically proven primary testicular CD20-positive diffuse large B-cell
             non-Hodgkin's lymphoma, untreated

          4. Ann Arbor stage IE or IIE. Bilateral testicular involvement at presentation will not
             be considered stage IV. In these patients the final Ann Arbor stage will be determined
             by the extent of nodal involvement.

          5. Bidimensionally measurable or evaluable disease. Patients who have had all disease
             removed by surgery are eligible.

          6. Adequate bone marrow reserve (ANC > 1.000/L, Plt > 100.000/L)

          7. Cardiac ejection fraction ≥ 50% by MUGA scan or echocardiography

          8. No previous therapy with monoclonal antibody anti-CD20.

          9. No psychiatric illness that precludes understanding concepts of the trial or signing
             informed consent

         10. No other major life-threatening illnesses that may preclude chemotherapy

         11. Have given written informed consent prior to any program-specific screening procedure,
             with the understanding that the consent may be withdrawn by the patient at any time
             without prejudice

        Exclusion Criteria:

          1. impairment of renal function (creatinine > 2 mg/dl) or liver function (bilirubin > 2
             mg/dl) unless due to lymphoma involvement

          2. HIV positive patients

          3. evolutive malignancy within 5 years with the exception of localized non-melanomatous
             skin cancer
Clinical trial NCT00700180 (phase 2, status: completed)
Conditions: non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: bevacizumab [avastin], bevacizumab [avastin], carboplatin-based chemotherapy
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [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
Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  locally advanced metastatic or recurrent non-squamous non-small cell lung cancer
             (NSCLC);

          -  >=1 measurable tumor lesion;

          -  ECOG performance status 0-1.

        Exclusion Criteria:

          -  prior chemotherapy or treatment with another systemic anti-cancer agent;

          -  evidence of CNS metastases;

          -  history of grade 2 or higher hemoptysis;

          -  evidence of tumor invading or abutting major blood vessels;

          -  malignancies other than NSCLC within 5 years prior to randomization, other than
             adequately treated cancer in situ of cervix, basal or squamous cell skin cancer,
             localized prostate cancer or DCIS;

          -  clinically significant cardiovascular disease;

          -  current or recent use of aspirin (>325mg/day) or full dose anticoagulants or
             thrombolytic agents for therapeutic purposes.
Clinical trial NCT01135498 (phase 2, status: completed)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: bevacizumab [avastin], eloxatin, capecitabine [xeloda], erlotinib [tarceva]
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, CCCCCOC(=O)NC1=NC(=O)N(C=C1F)[C@@H]1O[C@H](C)[C@@H](O)[C@H]1O, COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2
Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  adenocarcinoma of colon or rectum, with metastatic disease;

          -  >=1 measurable lesion.

        Exclusion Criteria:

          -  previous treatment with Avastin or Tarceva;

          -  previous systemic treatment for advanced or metastatic disease;

          -  adjuvant treatment for non-metastatic disease in past 6 months.
Clinical trial NCT01262352 (phase 2, status: completed)
Conditions: cystic fibrosis
ICD codes: E84.9, Z14.1, E84.0, E84.11, E84.8, E84.19, P09.4
Drugs: ivacaftor, placebo
SMILES: CC(C)(C)C1=CC(=C(O)C=C1NC(=O)C1=CNC2=CC=CC=C2C1=O)C(C)(C)C, 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 subjects with confirmed diagnosis of CF

          -  Must have the G551D-CFTR mutation in at least 1 allele

          -  FEV1 >90% of predicted normal for age, gender, and height

        Exclusion Criteria:

          -  Ongoing participation in another therapeutic clinical study or prior participation in
             an investigational drug study within the 30 days prior to screening

          -  Use of inhaled hypertonic saline treatment within 2 weeks of the Period 1, Day 1 visit
Clinical trial NCT00362141 (phase 2, status: unknown status)
Conditions: status epilepticus
ICD codes: G40.803, G40.804, G40.823, G40.824, G40.833, G40.834, G40.911
Drugs: levetiracetam (add-on)
SMILES: CC[C@H](N1CCCC1=O)C(N)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Age: ≥18 years of age

          -  All types of SE, diagnosed by the medical examiner according to the predefined
             definition. Absence SE has to be confirmed by EEG.

          -  Woman: 18-50 years of age of whom is known, from anamnesis or hetero-anamnesis (first
             line relative), that she is not pregnant.

        Exclusion Criteria:

          -  Woman < 50 years of age, without information on pregnancy

          -  Known pregnancy

          -  Known allergy for levetiracetam

          -  Daily dose levetiracetam of more than 2000mg/day
Clinical trial NCT00738374 (phase 2, status: completed)
Conditions: lymphocytic leukemia, chronic
ICD codes: C91.11, C91.12, C91.10
Drugs: rituximab [mabthera/rituxan], chlorambucil
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, OC(=O)CCCC1=CC=C(C=C1)N(CCCl)CCCl
Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=60 years of age;

          -  CD20+ chronic lymphocytic leukemia (CLL);

          -  no previous treatment for CLL;

          -  ECOG performance status 0-1.

        Exclusion Criteria:

          -  co-morbid conditions requiring long term use of systemic corticosteroids during study
             treatment;

          -  history of severe cardiac disease;

          -  transformation to aggressive B-cell malignancy.