Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Randomised, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 Versus Placebo Over 104 Weeks in the Prevention of Recurrence of Diverticulitis.
Brief Summary: The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.


Options:
A: Inclusion Criteria:

* age ≥ 18 years
* both males and females patients
* positive history of acute diverticulitis flare during the last year. The patients will be recruited only after the complete clinical remission of diverticulitis flare.
* patients who have given their free and informed consent

Exclusion Criteria:

* complicated diverticulitis(fistulas, stenosis, abscesses and/or bleeding)
* ascertained hypersensitivity to the salicylates
* any severe pathology that can interfere with the treatment or the clinical or instrumental test of the trial
* clinically significant renal or hepatic impairment
* esophageal, gastric or duodenal ulcer within 30 days prior to randomisation
* patients with active malignancy of any type, or history of a malignancy (patients with a history of malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable)
* treatment with any investigational drug within the previous 30 days
* treatment with lactulose or with any compound that lowering the colonic pH can prevent the release of the active moiety from the tablets
* recent history or suspicion of alcohol abuse or drug addiction
* patients who become unable to conform to protocol
* patients with ascertained pregnancy
* previous participation in this study
B: Inclusion Criteria:

* adults with CT sign of acute colonic uncomplicated diverticulitis
* elevated CRP and LPK
* Temp.38c or more

Exclusion Criteria:

* patients with peritonitis, sepsis or CT- sign of complicated diverticulitis with abscesses or free abdominal air
* pregnancy
* immunological incompetence and immunosuppressive therapy
C: Inclusion Criteria:

1. Males and females =\>18yrs of age.
2. If female of childbearing potential (FOCP), has demonstrated a negative beta HCG (human chorionic gonadotropin) serum pregnancy test, and agrees to comply with any applicable contraceptive requirements of the protocol
3. An episode of acute diverticulitis that resolved without colonic resection.
4. Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon with at least three diverticula noted

Exclusion Criteria:

1. Previous colorectal surgery, including surgical intervention for diverticular disease (with the exception of haemorrhoidectomy, colonic removal of polyps, and appendectomy)
2. Active peptic ulcer disease
3. History of or current presence of inflammatory bowel disease (IBD)
4. Subjects with active irritable bowel syndrome (IBS) requiring ongoing medication
5. Allergy or hypersensitivity to aspirin or related compounds
6. Allergy to radiologic contrast agents
7. Use of another Investigational product within 30 days of Baseline
8. Use of antibiotic therapy within 4 weeks of Baseline
9. Within 14 days of Baseline, use of prebiotic, probiotic or 5-ASA medications, as well as drugs active at the 5HT-receptor or anti-spasmodic agents
10. Use of systemic or rectal steroids within 6 weeks of Baseline. Use of inhaled or nasal steroids is acceptable
11. Use of anti-inflammatory drugs, (NSIADs, COX-2 inhibitors) including aspirin (except for cardiac prophylaxis) and ibuprofen, on a regular and ongoing basis
12. History of alcohol or other substance abuse within the previous year
13. Active or recent history of endometriosis or dysmenorrhoea within 6 months prior to Baseline
14. Females who are lactating
D: Inclusion Criteria:

* diagnosis of diverticular disease diagnosed for the first time or established by previous colonoscopy
* symptomatic episode of uncomplicated diverticular disease no more than 4 weeks prior to study entry
* patients who have given their free and informed consent.

Exclusion Criteria:

* acute diverticulitis (both complicated and uncomplicated)
* diverticular colitis
* active or recent peptic ulcer
* chronic renal insufficiency
* allergy to salicylates
* patients with intended or ascertained pregnancy, lactation
* women of childbearing age not using contraceptives
* lactulose-lactitol use in the two weeks before the enrolment and during the study
* presence of diverticulitis complications (fistulas, abscesses, and/or stenoses)
* use of probiotic preparations either prescribed or over-the counter within two weeks prior to study entry
* inability to give a valid informed consent or to properly follow the protocol
* patients with active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment were also acceptable)
* recent history or suspicion of alcohol abuse or drug addiction
* any severe pathology that can interfere with the treatment or the clinical or instrumental tests of the trial
* use of NSAIDS for one week before and throughout the study period (only paracetamol was permitted).

Answer: C