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#1 2018-01-13 04:31:26

JudsonElsa
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C) have an approximate 45% reduction in pioglitazone and total pioglitazone (pioglitazone, M-III, and M-IV) mean peak concentrations but no change in the mean AUC values.

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Six of these nine patients continued to receive pioglitazone hydrochloride, two patients were noted to have the CPK elevation on the last day of dosing and one patient discontinued pioglitazone hydrochloride due to the elevation.

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In response to regulatory changes that were adopted during the trial, the data and safety monitoring board approved additional exclusions for a history of heart failure, bladder cancer, or certain conditions that increased the risk of bladder cancer.

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