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| The interaction between simvastatin and fenofibrate with resultant reduction in AUC of simvastatin acid by around 40% was addressed. Namely, the applicant attempted to resolve the impact of this on the long-term effects of simvastatin, and address whether there is a potential for mitigation of the expected benefits of simvastatin in the high risk population purely due to the administration of the FDC, in part by demonstrating that the interaction is present to an apparently similar degree for the free association administered at different times. |
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