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03/16/14 2:54 PM

#175584 RE: DewDiligence #175580

ICPT - mea culpa

Picked up the wrong N*.

Cholesterol effects still favorable.**






* There were 217 patients randomized to
one of three groups in the trial: placebo, 10 mg OCA, or 5 mg OCA for six months titrated to 10 mg OCA based on clinical
response; 216 patients were dosed.

** Overall, serious adverse events (SAEs) occurred in 22 (10%) of the patients and, although there were more SAEs in the OCA treatment groups, none were considered drug-related and there were no apparent patterns in the SAEs. PBC patients typically have significantly elevated HDL cholesterol levels and modest decreases in HDL were observed in both OCA dose groups, similar to those seen in the prior PBC clinical trials. In addition, slight decreases in
triglycerides but no change in LDL cholesterol were observed in the OCA dose groups.