Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Open-Label, Randomized, Allopurinol-Controlled Study to Assess the Long-Term Safety of Oral Febuxostat in Subjects With Gout
Brief Summary: The purpose of this study is to determine the long-term safety of febuxostat, once daily (QD), compared to allopurinol in reducing serum urate levels in subjects with gout.


Options:
A: Inclusion Criteria:

* Hyperuricemia (serum urate ≥8.0 mg/dL and gout by American Rheumatism Association Criteria
* Renal function defined as a serum creatinine level of \< 2.0 mg/dL and creatinine clearance of \> 20 milliliters per minute (mL/min) by Cockroft and Gault formula.

Exclusion Criteria:

* History of xanthinuria
* Intolerance to allopurinol
* Presence of renal calculi,
* Alcohol intake of ≥ 14 drinks/week
* Clinically significant medical condition
B: Inclusion Criteria:

* Is receiving thiazide diuretic therapy (only to subjects randomized to or receiving febuxostat).
* Has a serum urate level less than 8.0 mg/dL and is not taking uric acid-lowering therapy (other than allopurinol or febuxostat).
* Has participated in a clinical study in which febuxostat was administered.
* Is completing Phase 3 Studies C02-009 or C02-010.
* Must not have experienced any serious study drug-related adverse events in the previous study.
* Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study

Exclusion Criteria:

* Has had any other significant medical condition as defined by the investigator that would interfere with the treatment, safety, or compliance with the protocol.
* Is intolerant of allopurinol.
C: Inclusion Criteria:

* First medical contact for acute attack of gout.
* ACR criteria for acute attack of gout
* Crystal proven by arthrocentesis on day of enrollment
* Primary gout

Exclusion Criteria:

* Secondary Gout
* Tophaceous Gout
* Prior steroid, colchicine, or uric acid lowering therapy in the past 6 months.
* Uncontrolled CHF
* Unstable angina
* Renal insufficiency (entry CREAT \> 1.3)
* Anticoagulant therapy
* Immunosuppressive therapy or chemotherapy in the past 6 months
* Pregnancy; OR
* Known allergy to NSAID, colchicine, or allopurinol
D: Inclusion Criteria:

* Has one or more of the American Rheumatism Association criteria for the diagnosis of gout.
* Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
* Must have a serum urate level greater than or equal to 8.0 milligram per deciliter (mg/dL).

Exclusion Criteria:

* Have a severe, unstable, or life threatening medical condition that would likely prevent them from completing this study.
* Has a known body reaction to febuxostat, allopurinol, naproxen, any other non-steroidal anti-inflammatory drug (NSAID), aspirin, lansoprazole, colchicine, or any components in their formulation.
* History of xanthinuria.
* Alcohol consumption greater than 14/week.
* History of significant concomitant illness.
* Active liver or peptic ulcer disease.
* Has rheumatoid arthritis requiring treatment.
* Has estimated creatinine clearance less than 30 milliliter per minute (mL/min) calculated using the Cockcroft-Gault formula corrected for ideal body weight.
* Requires therapy with any other urate-lowering drug other than the study drug; long-term use of NSAIDs and COX-2 inhibitors; salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; intravenous (IV) colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole;trimethoprim.

Answer: B