Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative Colitis
Brief Summary: The purpose of this study is to compare the maintenance of mild to moderate ulcerative colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day versus placebo.


Options:
A: Inclusion Criteria:

1. More than 18 years of age
2. Patients suffering from one of the following chronic inflammatory intestinal disease:

   * Steroid-dependent Chron's Disease or Ulcerative Colitis following ECCO definition or mild-moderate active UC ( Powell Tuck between 3 and 14- an index of 14 was allowed; endoscopic Baron score \>1) refractory to mesalazine.
3. Disease extension over the rectum (at least 15 cm) in patients suffering from Ulcerative Colitis
4. Patients willing and be able to give written informed consent.

Exclusion Criteria:

1. Intestinal sub occlusion or a suspected abdomen abscess or a severe degree of the disease (CDAI \> 450) in patient suffering from Chron's Disease
2. Patient affected by a severe Ulcerative Colitis (more than 6 evacuations of liquid, mucous-blooding stools combined at least one systemic sign as body temperature \> 37.8 °C, heart rate \< 90 bpm, ESR \> 30 mm/h or haemoglobin \< 10.5 g/dL)
3. Severe concurrent disease(s) as:

   * Medullar deficit: white blood cells \< 3000/mm3; platelets \< 75000/mm3; haemoglobin \< 10 g/dL;
   * Hepatic diseases presenting total bilirubin ≥ 3 mg/dL; AST (GOT) ≥ 5 UNL; alkaline phosphatase ≥ 5 UNL:
   * Renal failure with serum creatinine ≥ 3 mg/dL;
   * Heart failure
   * Respiratory failure
   * Disabling neurological diseases
   * Neoplasia
   * Patient deemed candidate to surgery due to Chron's Disease or Ulcerative Colitis
   * Chronic alcohol or drug abuse
   * Patient for whom the use of steroids is contraindicated (e.g. systemic infections)
4. Treatment with Infliximab in the previous 4 months
5. Pregnant woman or female for whom the possibility of a pregnancy during the study could not be excluded.
6. Non-collaborating patient or subject unable to regularly undergo the scheduled study procedures.
B: Inclusion Criteria:

* Confirmed diagnosis of ulcerative colitis and in remission for at least 1 month.
* Greater than 18 years of age.

Exclusion Criteria:

* Allergy/intolerance to aspirin, mesalamine or other salicylates.
* Prior bowel surgery other than appendectomy.
* Pregnancy, at risk of pregnancy or lactating.
* HIV or hepatitis B or C.
C: Inclusion Criteria:

In addition to others,

* Men or women age 18-75
* Diagnosis of ulcerative colitis confirmed through screening endoscopy.
* Extent of disease must involve at least the left colon
* Moderate to severe disease (Mayo Score 6-12). Systemic features of tachycardia, fever, and/or significant anemia should not be present.
* Inadequate response despite treatment with prednisone 40 - 50 mg/day (or other oral steroid at equivalent dose) orally for a minimum of 14 days immediately preceding study entry

Exclusion Criteria:

In addition to other protocol-defined conditions,

* Pregnancy
* Stool study that shows presence of ova and parasites, significant bacterial pathogens, or C. difficile toxin
* Colitis that is indeterminate, suggestive of Crohn's disease, or isolated to the rectum, based on endoscopic and/or biopsy findings
* Severely ill patients as evidenced by protocol-defined systemic criteria
* Chest radiograph abnormalities consistent with an infectious process
* History of colonic dysplasia
* HIV infection
* Known viral Hepatitis B or C infection
* History of or exposure to tuberculosis within 6 months before study entry
D: Inclusion Criteria:

* Subjects with active UC on either 5-ASA,corticosteroids,azathioprine(AZA) and or/6-mercaptopurine(6-MP);
* Mayo score of 6 to 10 points with moderate to severe disease on endoscopy
* Subjects on the following medications;

  1. prednisolone ≤ 20 mg daily (or equivalent) (dose must be stable for at least 2 weeks prior to study drug administration)
  2. 5-ASA (dose must be stable for at least 4 weeks prior to study drug administration)
  3. AZA or 6-MP (dose must be stable for at least 3 months prior to study drug administration)
  4. Rectal steroids or 5-ASA (must have been stable for at least 4 weeks prior to study drug)

Exclusion Criteria:

* Anti-TNF therapy within 8 weeks before study drug administration
* Contraindication to colonoscopy or sigmoidoscopy
* Primary or secondary immunodeficiency
* Autoimmune disease besides UC, with the exceptions of Sjogren's syndrome or hypothyroidism
* History of malignancy, excluding adequately treated and cured basal or squamous cell of the skin, or cervical carcinoma in situ
* Evidence of acute or chronic infection
* Clinically significant disease requiring medication

Answer: B