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Wednesday, 04/12/2017 9:57:50 PM

Wednesday, April 12, 2017 9:57:50 PM

Post# of 8473
The Company believes the high concentrations of the active ingredient and its primary metabolite attained in first pass absorption and processing by the liver resulted in the delayed toxicity exhibited in roughly 3-4% of the women administered the 50 mg dose of the drug in Phase III studies. At 12.5 mg there were no adverse liver toxicity signals different than placebo. The maximum concentrations of parent and metabolite for the 12.5 mg dose were 25% of the 50 mg dose.
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