araag2/HINT huggingface dataset:
Clinical trial NCT00666718 (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: insulin glargine, insulin lispro protamine suspension (ilps), insulin lispro
SMILES: [Na+].[Na+].[O-]P([O-])(F)=O, [Na+].[Na+].[O-]P([O-])(F)=O, [Na+].[Na+].[O-]P([O-])(F)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Diabetes Mellitus, Type 2

          -  Have been receiving metformin and at least one other oral antihyperglycemic medication
             (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit
             1 (Screening)

          -  Hemoglobin A1C (HbA1c) greater than or equal to 7.5% and less than or equal to 11.0%

          -  Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m^2

          -  Capable and willing to follow the protocol

          -  Give written consent

        Exclusion Criteria:

          -  Are taking any glucose-lowering agents (other than those listed in the inclusion
             criteria above)

          -  Have a history of severe hypoglycemia in the past 6 months

          -  Are pregnant or may become pregnant

          -  Women who are breastfeeding

          -  Have significant cardiac disease

          -  Have significant renal or liver disease

          -  Undergoing therapy for a malignancy

          -  Contraindications to the study medications

          -  Have an irregular sleep/wake cycle

          -  Have a serious disease or any condition considered by the investigator to be
             exclusionary
Clinical trial NCT00713310 (phase 3, status: completed)
Conditions: ulcerative colitis
ICD codes: K51.80, K51.813, K51.814, K51.90, K51.913, K51.914, K51.811
Drugs: asacol 400 mg, asacol 400 mg
SMILES: NC1=CC(C(O)=O)=C(O)C=C1, NC1=CC(C(O)=O)=C(O)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  are male or female between the ages of 5 and 17 years, inclusive, at the time of the
             first dose of study medication, with a history of biopsy and endoscopy confirmed UC;

          -  have mildly-to-moderately active UC (either newly diagnosed or that has relapsed) as
             defined clinically by a Pediatric UC Activity Index (PUCAI) score 10 and 55, and, in
             the opinion of the Investigator, the patient does not require steroids;

          -  have baseline scores of at least 1 for both rectal bleeding (Streaks of blood with
             stool less than half of the time) and stool frequency (1-2 stools greater than normal
             per day) as defined by the TM-Mayo Score

        Exclusion Criteria:

          -  have UC known to be confined to the rectum (isolated rectal proctitis);

          -  have a history of allergy or hypersensitivity to salicylates, aminosalicylates, or any
             component of the Asacol tablet;

          -  have a significant co-existing illness or other condition(s), including but not
             limited to cancer or significant organic or psychiatric disease on medical history or
             physical examination, that, in the judgment of the Investigator, contraindicate(s)
             administration of the study drug and/or any study procedures
Clinical trial NCT00423683 (phase 3, status: terminated)
Conditions: cancer, thromboembolism
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, O88.22, O88.23, O88.211, O88.212, O88.213, O88.219
Drugs: arixtra alone
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
Reason stopped: 
    study accrual stopped due to poor accrual.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Documentation of cancer.

          -  The disease may be a solid tumor, Lymphoma or Multiple Myeloma. Pathology reports will
             be documented in the patient's chart and included in the data.

          -  Age > 18 years

          -  An acute, radiographically confirmed, de novo Deep Vein Thrombosis (DVT) or Pulmonary
             Embolism (PE)

          -  No past medical history of a prior thrombus or known thrombophilia

        Exclusion Criteria

          -  Patients are not eligible for this study if they receive therapeutic doses of any
             heparin for more than 72 hours before randomization 31.

          -  Already receiving oral anticoagulant therapy 31.

          -  Severe renal impairment, calculated using the Cockcroft-Gault formula, defined as a
             creatinine clearance <30 mL/min 31.

          -  Platelet count of less than 50,000 per cubic millimeter

          -  Bleeding from the gastrointestinal tract that requires blood transfusion (s),
             intracranial bleeding or retroperitoneal bleeding.

          -  An indication for thrombolysis

          -  Allergy to iodine

          -  Hereditary thrombophilia

          -  Pregnancy

          -  Likelihood of noncompliance

          -  It is contraindicated to anticoagulate patients with brain metastasis secondary to
             melanoma, choriocarcinoma, renal cell and medullary thyroid carcinoma. If these
             patients have a Venous Thromboembolism (VTE), it is standard of care for these
             patients to have a CT of their head to evaluate if there is metastasis to the brain
             before they are anticoagulated 38. If these patients do have brain metastasis, they
             will not be included in the study.
Clinical trial NCT00536484 (phase 3, status: completed)
Conditions: overactive bladder
ICD codes: N32.81
Drugs: fesoterodine, placebo
SMILES: CC(C)N(CC[C@H](C1=CC=CC=C1)C1=C(OC(=O)C(C)C)C=CC(CO)=C1)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:

          -  Overactive bladder symptoms for greater than or equal to 3 months.

          -  Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in
             bladder diary.

          -  Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder
             diary.

        Exclusion Criteria:

          -  Contraindication to fesoterodine (antimuscarinics).

          -  Known etiology of OAB (e.g., neurogenic, local urinary tract pathology).

          -  Previous history of acute urinary retention requiring catheterization or severe
             voiding difficulties in the judgment of the investigator, prior to baseline.

          -  Unable to follow the study procedures, including completion of self-administered
             bladder diary and patient reported outcome questionnaires.
Clinical trial NCT00536510 (phase 3, status: completed)
Conditions: hypercholesterolemia, hyperlipidemia
ICD codes: E78.01, E78.00, Z83.42, E78.2, E78.49, E78.5
Drugs: laropiprant/niacin (mk0524a), comparator: placebo
SMILES: CS(=O)(=O)C1=C2N(CC3=CC=C(Cl)C=C3)C3=C(CC[C@@H]3CC(O)=O)C2=CC(F)=C1, CN(C)C(=N)NC(N)=N
Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female between 18 and 70 years of age

          -  Females of reproductive potential must agree to take acceptable contraceptive
             precautions for the duration of the study

        Exclusion Criteria:

          -  Patient has a history of not being able to take niacin or niacin-containing products

          -  Patient consumes more than 2 alcoholic beverages per day

          -  Patient has poorly controlled Type 1 or Type 2 diabetes mellitus

          -  Patient engages in vigorous exercise or an aggressive diet regimen
Clinical trial NCT01119937 (phase 3, status: completed)
Conditions: chronic obstructive pulmonary disease
ICD codes: J44.9, J44.1, J44.0
Drugs: nva237, tiotropium
SMILES: C[N+]1(C)CCC(C1)OC(=O)C(O)(C1CCCC1)C1=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:

          -  Patients with moderate to severe stable COPD (Stage II or Stage III) according to the
             Gold Guideline 2008.

          -  Current or ex-smokers who have a smoking history of at least 10 pack years.

          -  Patients with a post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and
             postbronchodilator FEV1/FVC < 0.7 at Visit 2 (day -7)

        Exclusion Criteria:

          -  Pregnant women or nursing mothers or women of child-bearing potential not using an
             acceptable method of contraception

          -  Patients requiring long term oxygen therapy

          -  Patients who have had a lower respiratory tract infection within 6 weeks prior to
             Visit 1

          -  Patients with concomitant pulmonary disease

          -  Patients with a history of asthma

          -  Any patient with lung cancer or a history of lung cancer

          -  Patients with a history of certain cardiovascular comorbid conditions

          -  Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency

          -  Patients in the active phase of a supervised pulmonary rehabilitation program

          -  Patients contraindicated for tiotropium or ipratropium treatment or who have shown an
             untoward reaction to inhaled anticholinergic agents

          -  Other protocol-defined inclusion/exclusion criteria may apply
Clinical trial NCT00399711 (phase 3, 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: repaglinide and metformin combination tablet, rosiglitazone and metformin combination tablet
SMILES: CCOC1=C(C=CC(CC(=O)N[C@@H](CC(C)C)C2=CC=CC=C2N2CCCCC2)=C1)C(O)=O, CN(CCOC1=CC=C(CC2SC(=O)NC2=O)C=C1)C1=CC=CC=N1
Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes for at least 3 months

          -  HbA1c between 7.5-11.0% on monotherapy or

          -  HbA1c between 7.0-10.0% on dual therapy

          -  BMI maximum 45 kg/m2

        Exclusion Criteria:

          -  Any clinically significant disease history in the opinion of the investigator

          -  Severe heart disease

          -  Pregnancy
Clinical trial NCT00234910 (phase 3, status: completed)
Conditions: hiv infection
ICD codes: Z21
Drugs: tenofovir df, lopinavir/ritonavir with 2 nucleoside rtis
SMILES: [H][C@@](C)(CN1C=NC2=C(N)N=CN=C12)OCP(=O)(OCOC(=O)OC(C)C)OCOC(=O)OC(C)C, 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:

          -  HIV positive

          -  >18 years of age

          -  HIV RNA> 400 copies/mL

          -  Any CD 4 cell count

          -  Antiretroviral naïve

          -  No acute illness

        Exclusion Criteria:

        -
Clinical trial NCT01313637 (phase 3, status: completed)
Conditions: pulmonary disease, chronic obstructive
ICD codes: J44.9, J44.1, J44.0
Drugs: gsk573719/gw642444 125/25mcg, gsk573719 125mcg, gw642444 25mcg, placebo only
SMILES: OCC1=C(O)C=CC(=C1)[C@@H](O)CNCCCCCCOCCOCC1=C(Cl)C=CC=C1Cl, OC(C1=CC=CC=C1)(C1=CC=CC=C1)C12CC[N+](CCOCC3=CC=CC=C3)(CC1)CC2, 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:

          -  Diagnosis of COPD

          -  10 pack-year or greater history of cigarette smoking

          -  Post-bronchodilator FEV1/FVC of <0.7

          -  Predicted FEV1 of 70% of normal or less

          -  Modified Medical Research Council (mMRC) dyspnea score of 2 or greater

        Exclusion Criteria:

          -  Women who are pregnant, lactating, or planning to become pregnant

          -  Respiratory disorders other than COPD, including a current diagnosis of asthma

          -  Clinically significant non-respiratory diseases or abnormalities that are not
             adequately controlled

          -  Significant allergy or hypersensitivity to anticholinergics, beta2-agonists, or the
             excipients of magnesium stereate or lactose used in the inhaler delivery device

          -  Hospitalization for COPD or pneumonia within 12 weeks prior to screening

          -  Lung volume reduction surgery within 12 weeks prior to screening

          -  Abnormal and clinically significant ECG findings at screening

          -  Clinically significant laboratory findings at screening

          -  Use of systemic corticosteroids, antibiotics for respiratory tract infections, strong
             cytochrome P450 3A4 inhibitors, high dose inhaled steroids (>1000mcg fluticasone
             propionate or equivalent), PDE4 inhibitors, tiotropium, oral beta2-agoinists, short-
             and long-acting inhaled beta2-agonists, ipratropium, inhaled sodium cromoglycate or
             nedocromil sodium, or investigational medicines for defined time periods prior to the
             screening visit

          -  Use of long-term oxygen therapy (12 hours or greater per day)

          -  Regular use of nebulized treatment with short-acting bronchodilators

          -  Participation in the acute phase of a pulmonary rehabilitation program

          -  A know or suspected history of alcohol or drug abuse

          -  Affiliation with the investigational site

          -  Previous use of GSK573719 or GW642444 alone or in combination, including the
             combination of fluticasone furoate and GW642444
Clinical trial NCT01508026 (phase 3, status: completed)
Conditions: stage 1 hypertension, stage 2 hypertension
ICD codes: I15.0, I97.3, K76.6, P29.2, G93.2, H40.053, I10
Drugs: nebivolol and valsartan 1, nebivolol and valsartan 2, nebivolol and valsartan 3, nebivolol 1, nebivolol 2, valsartan 1, valsartan 2, placebo
SMILES: OC(CNCC(O)C1CCC2=C(O1)C=CC(F)=C2)C1CCC2=C(O1)C=CC(F)=C2, OC(CNCC(O)C1CCC2=C(O1)C=CC(F)=C2)C1CCC2=C(O1)C=CC(F)=C2, OC(CNCC(O)C1CCC2=C(O1)C=CC(F)=C2)C1CCC2=C(O1)C=CC(F)=C2, OC(CNCC(O)C1CCC2=C(O1)C=CC(F)=C2)C1CCC2=C(O1)C=CC(F)=C2, OC(CNCC(O)C1CCC2=C(O1)C=CC(F)=C2)C1CCC2=C(O1)C=CC(F)=C2, CCCCC(=O)N(CC1=CC=C(C=C1)C1=CC=CC=C1C1=NNN=N1)[C@@H](C(C)C)C(O)=O, CCCCC(=O)N(CC1=CC=C(C=C1)C1=CC=CC=C1C1=NNN=N1)[C@@H](C(C)C)C(O)=O, 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 outpatients of age 18 years or above

          -  Patients diagnosed with stage 1 or stage 2 essential hypertension

          -  Normal physical examination findings, electrocardiogram (ECG) results and chest x-ray;
             or abnormal findings judged by the Investigator to be not clinically significant

        Exclusion Criteria:

          -  Secondary hypertension or severe hypertension

          -  Clinically significant cardiovascular disease or heart failure

          -  Clinical significant respiratory disease that would prohibit the use of a beta blocker

          -  A medical contraindication to discontinuing a current antihypertensive therapy

          -  History of Type 1 diabetes mellitus

          -  History of Severe Mental Illness except mild depression
Clinical trial NCT00161200 (phase 3, status: terminated)
Conditions: esophageal metaplasia
ICD codes: K22.2, K22.81, Q39.4, P78.83, I85.00, I85.01, I85.10
Drugs: ranitidine & pantoprazole
SMILES: CN\C(NCCSCC1=CC=C(CN(C)C)O1)=C/[N+]([O-])=O
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Dyspeptic symptoms, upper abdominal pain, heartburn, regurgitation;

          -  Endoscopically - normal appearing GE junction, irregular z-line, or erosive
             esophagitis up to Grade 2.

        Exclusion Criteria:

          -  Barrett's esophagus (Endoscopically greater than 2 cm of columnar epithelium on
             endoscopy and the presence of specialized columnar epithelium on histology);

          -  Patients who have been taking a PPI longer than the 3 months proceeding study entry.
             Patients currently taking a PPI but for less than 3 months who are not willing to
             discontinue PPI treatment for 4 weeks prior to enrollment into this study.

          -  Severe esophagitis Grade 3 or 4

          -  Documented active duodenal or gastric ulcer (at least 0.5cm diameter). Patients with
             erosions can be included.

          -  Presence of esophageal varices

          -  History of gastric surgery altering normal anatomy (eg, Billroth procedure, gastric
             bypass)

          -  Pregnant or nursing patients
Clinical trial NCT00151255 (phase 3, status: completed)
Conditions: acute myeloid leukemia
ICD codes: C92.A1, C92.A2, C92.61, C92.62, C92.A0, C92.60
Drugs: cytarabine, idarubicin, all-trans retinoic acid, mitoxantrone, etoposid
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, [H][C@@]12C[C@H](N(C(=O)[C@H](C)N[C@@H](CCC3=CC=CC=C3)C(=O)OCC)[C@@]1([H])CCCC2)C(O)=O, C\C(\C=C\C1=C(C)CCCC1(C)C)=C/C=C/C(/C)=C/C(O)=O, OCCNCCNC1=CC=C(NCCNCCO)C2=C1C(=O)C1=C(C(O)=CC=C1O)C2=O, [H][C@]12COC(=O)[C@]1([H])[C@H](C1=CC(OC)=C(O)C(OC)=C1)C1=CC3=C(OCO3)C=C1[C@H]2O[C@@H]1O[C@]2([H])CO[C@@H](C)O[C@@]2([H])[C@H](O)[C@H]1O
Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed AML defined according to the World Health Organization (WHO)
             classification (excluding acute promyelocytic leukemia [APL])

          -  Aged > 60 years

          -  All patients have to be informed about the character of the study. Written informed
             consent of each patient at study entry.

          -  Molecular and cytogenetical analyses on initial bone marrow and peripheral blood
             specimen have to be performed at the central reference laboratories.

        Exclusion Criteria:

          -  Bleeding independent of the AML

          -  Acute promyelocytic leukemia

          -  Uncontrolled infection

          -  Participation in a concurrent clinical study

          -  Insufficiency of the kidneys (creatinine > 1.5 x upper normal serum level), of the
             liver (bilirubin, AST or AP > 2 x upper normal serum level), severe obstruction or
             restrictive ventilation disorder, heart failure New York Heart Association [NYHA]
             III/IV

          -  Severe neurological or psychiatric disorder interfering with ability of giving
             informed consent

          -  No consent for the registration, storage and processing of data concerning the
             characteristics of the AML and the individual course

          -  Performance status WHO > 2
Clinical trial NCT01578707 (phase 3, status: completed)
Conditions: relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma
ICD codes: A87.2, K52.832, D72.111, C91.11, C91.12, C91.10, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: ofatumumab, ibrutinib
SMILES: NC1=NC=NC2=C1C(=NN2[C@@H]1CCCN(C1)C(=O)C=C)C1=CC=C(OC2=CC=CC=C2)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  ECOG performance status of 0-1.

          -  Diagnosis of CLL or SLL that meets IWCLL 2008 criteria.

          -  Active disease meeting at least 1 of the IWCLL 2008 criteria for requiring treatment.

          -  Must have received at least one prior therapy for CLL/SLL.

          -  Considered not appropriate for treatment or retreatment with purine analog based
             therapy.

          -  Measurable nodal disease by CT.

          -  Patients must be able to receive outpatient treatment and laboratory monitoring at the
             institution that administers study drug for the entire study.

        Exclusion Criteria:

          -  Known CNS lymphoma or leukemia.

          -  No documentation of cytogenetic and/or FISH in patient records prior to first dose of
             study drug.

          -  Any history of Richter's transformation or prolymphocytic leukemia.

          -  Uncontrolled Autoimmune Hemolytic Anemia (AIHA) or idiopathic thrombocytopenia purpura
             (ITP).

          -  Prior exposure to ofatumumab or to ibrutinib.

          -  Prior autologous transplant within 6 months prior to first dose of study drug.

          -  Prior allogeneic stem cell transplant within 6 months or with any evidence of active
             graft versus host disease or requirement for immunosuppressants within 28 days prior
             to first dose of study drug.

          -  History of prior malignancy, with the exception of certain skin cancers and
             malignancies treated with curative intent and with no evidence of active disease for
             more than 3 years.

          -  Serologic status reflecting active hepatitis B or C infection.

          -  Unable to swallow capsules or disease significantly affecting gastrointestinal
             function.

          -  Uncontrolled active systemic fungal, bacterial, viral, or other infection.

          -  History of stroke or intracranial hemorrhage within 6 months prior to the first dose
             of study drug.

          -  Requires anticoagulation with warfarin.
Clinical trial NCT01431287 (phase 3, status: completed)
Conditions: pulmonary disease, chronic obstructive
ICD codes: J44.9, J44.1, J44.0
Drugs: tiotropium + olodaterol, tiotropium + olodaterol, tiotropium, tiotropium, olodaterol
SMILES: [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, [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, [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, [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, COC1=CC=C(CC(C)(C)NC[C@H](O)C2=C3OCC(=O)NC3=CC(O)=C2)C=C1
Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of chronic obstructive pulmonary disease.

          2. Relatively stable airway obstruction with post FEV1< 80% predicted normal and post
             FEV1/FVC <70%.

          3. Male or female patients, 40 years of age or older.

          4. Smoking history of more than 10 pack years.

        Exclusion criteria:

          1. Significant disease other than COPD

          2. Clinically relevant abnormal lab values.

          3. History of asthma.

          4. Diagnosis of thyrotoxicosis

          5. Diagnosis of paroxysmal tachycardia

          6. History of myocardial infarction within 1 year of screening visit

          7. Unstable or life-threatening cardiac arrhythmia.

          8. Hospitalization for heart failure within the past year.

          9. Known active tuberculosis.

         10. Malignancy for which patient has undergone resection, radiation therapy or
             chemotherapy within last five years

         11. History of life-threatening pulmonary obstruction.

         12. History of cystic fibrosis.

         13. Clinically evident bronchiectasis.

         14. History of significant alcohol or drug abuse.

         15. Thoracotomy with pulmonary resection

         16. Oral ß-adrenergics.

         17. Oral corticosteroid medication at unstable doses

         18. Regular use of daytime oxygen therapy for more than one hour per day

         19. Pulmonary rehabilitation program in the six weeks prior to the screening visit

         20. Investigational drug within one month or six half lives (whichever is greater) prior
             to screening visit

         21. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA

         22. Pregnant or nursing women.

         23. Women of childbearing potential not using a highly effective method of birth control

         24. Patients who are unable to comply with pulmonary medication restrictions