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Evaluation of patients at 4 years or longer was inadequate due to the urso high drop out rate and small number of patients .
Therefore, death, need for liver transplantation, histological progression by two stages or to cirrhosis, development of varices, ascites or encephalopathy, marked worsening of fatigue or urso pruritis, inability to tolerate the drug, doubling of serum bilirubin and voluntary withdrawal were not assessed .
A randomized, two-period urso crossover study in fifty PBC patients compared efficacy of URSO 250® (ursodiol) in BID (two) versus QID (four) divided dosing schedules in 50 patients for 6 months in each crossover period .
urso Mean percent changes from baseline in liver test results and Mayo risk score (n=46) and serum enrichment with UDCA (n=34) were not statistically significant with any dosage at any time interval .

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