anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Linagliptin
Trial phase: Phase 3
ATC code: A10BD11 | A10BD19 | A10BD27 | A10BH05
SMILES: CC#CCn1c(N2CCC[C@@H](N)C2)nc2c1c(=O)n(Cc1nc(C)c3ccccc3n1)c(=O)n2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 523
Group description: Patients randomized to receive treatment with Linagliptin 5 mg
Eligibility criteria:
Inclusion criteria:

Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone, or with metformin and not more than one other oral antidiabetic drug
Diagnosis of type 2 diabetes prior to informed consent

Glycosylated haemoglobin A1 (HbA1c)at screening:

For patients undergoing wash out of previous medication: HbA1c 6.5 - 9.0% For patients not undergoing wash-out of previous medication: HbA1c 7.0 - 10.0%

Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at the beginning of Placebo Run-in
Age 18 -80 years
BMI (Body Mass Index) less than 40 kg/m2
Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation

Exclusion criteria:

Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
Impaired hepatic function
Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo
Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to informed consent
Treatment with insulin within 3 months prior to informed consent
Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent
Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
Participation in another trial with an investigational drug within 2 months prior to informed consent

Pre-menopausal women who:

are nursing or pregnant,
or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
Renal failure or renal impairment
Unstable or acute congestive heart failure
Acute or chronic metabolic acidosis (present in patient history)
Hereditary galactose intolerance
Intervention: Orlistat
Trial phase: Not Applicable
ATC code: A08AB01
SMILES: CCCCCCCCCCC[C@@H](C[C@@H]1OC(=O)[C@H]1CCCCCC)OC(=O)[C@H](CC(C)C)NC=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
Eligibility criteria:
Inclusion Criteria:

Body mass index greater than 27
Binge eating at least two times per week during the 6 months prior to study entry

Exclusion Criteria:

Current psychosis
Current suicidal ideations
Pregnant
Receiving concurrent psychotherapy
Unstable on psychotropic medications for 3 months prior to study entry
Intervention: Naproxen
Trial phase: Phase 3
ATC code: G02CC02 | M01AE02 | M01AE52 | M01AE56 | M02AA12
SMILES: COc1ccc2cc([C@H](C)C(=O)O)ccc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 257
Group description: Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.

naproxen: Oral naproxen twice daily for 5-8 days.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of a non-hematologic (non-myeloid) malignancy
Scheduled to receive chemotherapy; chemotherapy may be given for adjuvant, neoadjuvant, curative, or palliative intent
Scheduled to receive the first dose of pegfilgrastim (Neulasta®) to ameliorate chemotherapy-induced neutropenia
Creatinine ≤ 1.5 times upper limit of normal
Able to understand English
More than 6 months since prior surgery on the heart

Exclusion Criteria:

Pregnant or nursing
Clinical evidence of active gastrointestinal bleeding, prior gastrointestinal bleeding, or gastric or duodenal ulcers
Allergy to naproxen
Prior development of the triad of asthma, rhinitis, and nasal polyps after taking acetylsalicylic acid (aspirin) or other NSAIDs
Concurrent nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or any product containing naproxen (e.g., Naprosyn, EC-Naprosyn, Anaprox, Anaprox-DS, Naprosyn suspension, or Aleve), on a regular basis
Concurrent steroids on a regular basis
Concurrent prescription or non-prescription medications for preexisting chronic pain; concurrent cardioprotective doses (≤ 325 mg/day) of aspirin allowed
Concurrent therapeutic doses of warfarin
Intervention: Deferasirox
Trial phase: Phase 2
ATC code: V03AC03
SMILES: O=C(O)c1ccc(-n2nc(-c3ccccc3O)nc2-c2ccccc2O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Includes patients that were treated with deferasirox for 6 months.
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of iron overload, defined as serum ferritin > 1,000 ng/mL and liver iron concentration ≥ 5 mg iron/g on tissue proton transverse relaxation rates Magnetic Resonance Imaging (MRI)
Underwent prior allogeneic hematopoietic stem cell transplantation (HSCT) using either myeloablative or reduced-intensity conditioning at least 12 months ago
No evidence of relapse or progression of the primary disease for which allogeneic HSCT was performed
Patients who have become red-cell transfusion independent (i.e., no red cell transfusions within the past 3 months) as well as patients who require red cell transfusions are eligible

Meets one of the following criteria:

Ineligible for phlebotomy (hemoglobin < 11 g/dL, poor intravenous access, or unable to undergo phlebotomy every 4 weeks)
Have failed treatment with phlebotomy (serum ferritin > 50% of baseline after 3 months of phlebotomy)
Refused phlebotomy
ECOG performance status of 0-2
Life expectancy ≥ 6 months
Adequate renal function defined as serum creatinine < or = 1.6 mg/dL and creatinine clearance of > or = 60 ml/min calculated using the Crockcroft-Gault formula on 2 occasions within 30 days of enrollment
Sexually active men and women must use an effective method of contraception. Alternatively, women must have undergone clinically documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal.
Must be able to give written informed consent.
Prior therapy with deferoxamine allowed provided it was completed ≥ 12 months ago

Exclusion Criteria:

Contraindication for performing MRI or inability to undergo MRI because of claustrophobia or weight (>350 pounds).
Inability to take medications orally.
Uncontrolled bacterial, viral, or fungal infection
ANC ≥ 1,000/mm³
Hemoglobin ≥ 8.0 g/dL
Platelet count ≥ 50,000/mm³
Aspartate aminotransferance (AST) and alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal
Less than 4 weeks since prior and no concurrent systemic investigational drug
Less than 7 days since prior and no concurrent topical investigational drug. Concurrent non-investigational medications needed to treat concomitant medical conditions are allowed, with the exception of other chelating agents. Concurrent growth factors such as epoetin alfa, darbepoetin alfa, filgrastim (G-CSF), and sargramostim (GM-CSF) allowed. Concurrent irradiated packed red-cell and platelet transfusions allowed as clinically indicated. Concurrent low-doses of vitamin C supplements (≤ 200 mg/day) allowed.
Concurrent iron supplements or multivitamins with iron.
Aluminum-containing antacid therapies may not be taken simultaneously with deferasirox, but may be taken 2 hours before or after administration of deferasirox
On dialysis or status post-renal transplantation
Pregnant or nursing
Intervention: Venlafaxine
Trial phase: Phase 4
ATC code: N06AX16
SMILES: COc1ccc(C(CN(C)C)C2(O)CCCCC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 140
Group description: Venlafaxine: 75 to 375 mg
Eligibility criteria:
Inclusion Criteria:

Meets DSM-IV criteria for Axis I bipolar II disorder
Meets DSM-IV criteria for Axis I major depressive episode
Score of 16 on 17-item HAM-D rating scale
Not taking monoamine oxidase inhibitors (MAOI) for more than 2 weeks prior to study entry
Willing to use an effective form of birth control throughout the study

Exclusion Criteria:

History of mania
Current primary Axis I diagnosis other than bipolar II disorder
Alcohol or drug dependence within 3 months prior to study entry
Contraindication to treatment with venlafaxine or lithium
Unstable medical condition (e.g., thyroid disease, hypertension, or angina pectoris)
Pregnant or breastfeeding
Experiencing suicidal thoughts
Requires hospitalization
Requires concurrent neuroleptic or MS therapy
Requires concurrent AD therapy
Current psychotic features
Inadequate trial of therapy at the time of initial screening visit
History of intolerance to either venlafaxine or lithium
Unlikely to participate in a 36-week trial
Presence of apparent secondary gain
Intervention: FLUTICASONE FUROATE
Trial phase: Phase 4
ATC code: R01AD12 | R03AK10 | R03AL08 | R03BA09
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)c3ccco3)(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@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 24
Group description: 55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy

fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy
Eligibility criteria:
Inclusion Criteria:

Age: between 2 and 12 years
Polysomnogram results showing AHI >5/hr irrespective of saturations
No other significant medical problems except well controlled asthma
No chronic medication intake except bronchodilators and leukotriene receptor antagonists
No systemic steroids within the past month
No intranasal steroids within the past 2 weeks

Exclusion Criteria:

Patients with OSAS who are overweight (BMI>95th percentile for age) or who have neurological or craniofacial abnormalities as these tend to have OSAS related to these factors per se.
Females of the specified age group who have already had their first period.
Intervention: Acyline
Trial phase: Phase 1 | Phase 2
SMILES: CC(=O)Nc1ccc(C[C@H](NC(=O)[C@H](CO)NC(=O)[C@@H](Cc2cccnc2)NC(=O)[C@@H](Cc2ccc(Cl)cc2)NC(=O)[C@@H](Cc2ccc3ccccc3c2)NC(C)=O)C(=O)N[C@H](Cc2ccc(NC(C)=O)cc2)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N2CCC[C@H]2C(=O)N[C@H](C)C(N)=O)cc1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: 20 mg dose of GIPET enhanced oral acyline for 7 days
Eligibility criteria:
Inclusion Criteria:

Healthy male
18-50 years of age
Non-smoker
Not taking any medications other than the study drug for the duration of the study.
Must be willing to use an accepted method of contraception during the study.

Exclusion Criteria:

BMI > 35
Abnormal evaluation on screening exam and labs
Known history of alcohol abuse, illicit drugs or steroids and/or use of more that 3 alcoholic beverages/day
History of current testosterone use or infertility
History of testicular disease or severe testicular trauma
History of major psychiatric disorder or sleep apnea
History of bleeding disorder or need for anticoagulation
Current smoker or utilizing nicotine patches or gum
Participation in a hormonal drug study within past month.
Intervention: EXENATIDE
Trial phase: Phase 3
ATC code: A10BJ01
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 111
Group description: Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosed with type 2 diabetes
If treated with a thiazolidinedione (TZD) alone, the TZD dose must have been stable for at least 120 days
The dose of TZD must be: Rosiglitazone (≥4 mg/day) or pioglitazone (≥30 mg/day)
The metformin dose has been stable for at least 90 days
Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 10.0%, inclusive.
Have a body mass index (BMI): 25 kg/m2 < BMI < 45 kg/m2.

Exclusion Criteria:

Have participated in this study previously or any other study using exenatide (AC2993/LY2148568) or glucagon-like peptide-1 (GLP-1) analogs, or have been previously treated with exenatide or GLP-1 analogs
Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
Have been treated with exogenous insulin for more than 1 week within the 2 months prior to screening
Used drugs for weight loss (e.g., orlistat, rimonabant, sibutramine, or similar over-the-counter medications) within 3 months prior to screening.

Are currently treated with any of the following excluded medications:

Sulfonylurea or meglitinide derivatives (e.g., repaglinide or nateglinide) within 3 months prior to screening
Alpha-glucosidase inhibitor (e.g., miglitol or acarbose) within 3 months of screening
Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin or vildagliptin) within 3 months prior to screening
Pramlintide acetate injection within 3 months prior to screening
Drugs that directly affect gastrointestinal motility, including, but not limited to: Metoclopramide, cisapride, and chronic macrolide antibiotics
Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start
Intervention: Gabapentin
Trial phase: Phase 3
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 89
Group description: The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
Eligibility criteria:
Inclusion Criteria:

Japanese male or females, ages 3-15 years old at acquisition of informed consent, 15 years old or less at the baseline visit
Seizures are classified as simple partial, complex partial or partial becoming secondarily generalized (defined according to the International League Against Epilepsy)
Have not been able to achieve adequate seizure control with antiepileptic drugs

Exclusion Criteria:

Seizures related to drugs or acute medical illness
History of any serious medical or psychiatric disorder
Diagnosis or history of a structural CNS lesion or an encephalopathy shown to be progressive
Intervention: L-Name
Trial phase: Not Applicable
SMILES: COC(=O)C(N)CCCN=C(N)N[N+](=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 54
Group description: 10 individuals age 18-35 will be getting an infusion of L-NAME (a nitric oxide inhibitor) during 3 separate PET study days, then a 10-minute infusion of L-arginine to reverse effects of L-NAME.

L-NAME: nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging
Eligibility criteria:
Inclusion Criteria:

Between the ages of 18-35 or 60-75
Normal glucose tolerance test
Normal plasma fasting lipid panel (fasting total cholesterol less than 220 mg/dL)
Normal rest/stress echocardiogram
BMI (Body Mass Index) less than 30 kg/m2

Exclusion Criteria:

Coronary artery disease
High blood pressure
Current smoker
Diabetes mellitus
Cardiovascular disease (signs and symptoms of any kind)
History of stroke, peripheral vascular disease, or arrhythmia
Pregnant or breastfeeding
Intervention: Phenylephrine
Trial phase: Not Applicable
ATC code: C01CA06 | R01AA04 | R01AB01 | R01BA03 | R01BA53 | S01FB01 | S01FB51 | S01GA05 | S01GA55
SMILES: CNC[C@H](O)c1cccc(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 54
Group description: 10 individuals age 18-35 will be getting an infusion of phenylephrine (primarily an alpha agonist) during 3 separate PET study days

Phenylephrine: alpha agonist; 10 μg/kg/min infusion during PET study
Eligibility criteria:
Inclusion Criteria:

Between the ages of 18-35 or 60-75
Normal glucose tolerance test
Normal plasma fasting lipid panel (fasting total cholesterol less than 220 mg/dL)
Normal rest/stress echocardiogram
BMI (Body Mass Index) less than 30 kg/m2

Exclusion Criteria:

Coronary artery disease
High blood pressure
Current smoker
Diabetes mellitus
Cardiovascular disease (signs and symptoms of any kind)
History of stroke, peripheral vascular disease, or arrhythmia
Pregnant or breastfeeding
Intervention: Arginine
Trial phase: Not Applicable
ATC code: B05XB01 | V03AF11
SMILES: N=C(N)NCCC[C@H](N)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 54
Group description: 12 individuals age 18-35 will be getting an infusion of L-arginine 125 mcg/kg/min for 120 to 140 minutes during 3 separate PET study days

L-Arginine: aids in nitric oxide production
Eligibility criteria:
Inclusion Criteria:

Between the ages of 18-35 or 60-75
Normal glucose tolerance test
Normal plasma fasting lipid panel (fasting total cholesterol less than 220 mg/dL)
Normal rest/stress echocardiogram
BMI (Body Mass Index) less than 30 kg/m2

Exclusion Criteria:

Coronary artery disease
High blood pressure
Current smoker
Diabetes mellitus
Cardiovascular disease (signs and symptoms of any kind)
History of stroke, peripheral vascular disease, or arrhythmia
Pregnant or breastfeeding
Intervention: Arginine
Trial phase: Not Applicable
ATC code: B05XB01 | V03AF11
SMILES: N=C(N)NCCC[C@H](N)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 54
Group description: 12 individuals age 60-75 will be getting an infusion of L-arginine 125 mcg/kg/min for 120 to 140 minutes during 3 separate PET study days

L-Arginine: aids in nitric oxide production
Eligibility criteria:
Inclusion Criteria:

Between the ages of 18-35 or 60-75
Normal glucose tolerance test
Normal plasma fasting lipid panel (fasting total cholesterol less than 220 mg/dL)
Normal rest/stress echocardiogram
BMI (Body Mass Index) less than 30 kg/m2

Exclusion Criteria:

Coronary artery disease
High blood pressure
Current smoker
Diabetes mellitus
Cardiovascular disease (signs and symptoms of any kind)
History of stroke, peripheral vascular disease, or arrhythmia
Pregnant or breastfeeding
Intervention: L-Name
Trial phase: Not Applicable
SMILES: COC(=O)C(N)CCCN=C(N)N[N+](=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 54
Group description: 10 individuals age 60-75 will be getting an infusion of L-NAME (a nitric oxide inhibitor) during 3 separate PET study days, then a 10-minute infusion of L-arginine to reverse effects of L-NAME

L-NAME: nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging
Eligibility criteria:
Inclusion Criteria:

Between the ages of 18-35 or 60-75
Normal glucose tolerance test
Normal plasma fasting lipid panel (fasting total cholesterol less than 220 mg/dL)
Normal rest/stress echocardiogram
BMI (Body Mass Index) less than 30 kg/m2

Exclusion Criteria:

Coronary artery disease
High blood pressure
Current smoker
Diabetes mellitus
Cardiovascular disease (signs and symptoms of any kind)
History of stroke, peripheral vascular disease, or arrhythmia
Pregnant or breastfeeding
Intervention: MESALAMINE
Trial phase: Phase 3
ATC code: A07EC02
SMILES: Nc1ccc(O)c(C(=O)O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 143
Group description: 5-ASA (5-Aminosalicylate)

5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)
Eligibility criteria:
Inclusion Criteria for Active phase:

Newly diagnosed or recurrent, mild to moderate Ulcerative Colitis patients.
Extent of colonic involvement confirmed within the past 36 months
UCDAI score of at least 3 but not greater than 8 and a score of at least 1 for endoscopy
Screening tests to rule out any abnormalities in stool, heart or kidney.
Male or non-pregnant females between 18 to 75 years.
Women of childbearing potential to use efficacious contraception as judged by the investigator.
Written informed consent given.

Inclusion Criteria for Maintenance phase:

Newly recruited subjects with documented mild to moderate UC entering the Run-in Phase: in clinical remission for at least 1 month and for a maximum of 3 years, and receiving 5-ASA 1.4 to 2.5 g/day for maintenance of quiescent disease
Subjects from Active Phase: meeting remission criteria after the 8-week active period
Extent of colonic involvement confirmed within the past 36 months by colonoscopy
In complete remission at entry into the Maintenance Phase, defined as i) a score of 0 or 1 for stool frequency; ii) a score of 0 for rectal bleeding; iii) a score of 0 for endoscopy findings; and iv) a Physician's Global Assessment (PGA) score of 0 or 1
Screening tests to rule out any abnormalities in stool, heart or kidney.

Exclusion Criteria:

Use of 5-ASA products at a dose >2.5g/day within 7 days prior to entry.
Proctitis, short bowel syndrome, prior bowel surgery, severe UC, other forms of Inflammatory Bowel Disease
Infectious diseases, parasites, bacterial pathogens
Allergy to aspirin or salicylate
Liver or kidney abnormalities
Alcohol or drug abuse
Pregnancy
Cancer
Bleeding disorders, ulcers, autoimmune diseases
Mental disorders
Participation in clinical trial in last 30 days
Inability to fill in diary cards / comply with protocol requirements