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Every batch produced in a cGMP facility

2.3 Endpoints The primary endpoints were area under the plasma concentrationtime curve (AUC) from time 0 to 24 h at steady state (AUC 0-24,SS ) for ethinylestradiol (AUC 0-24,EE,SS ) and levonorgestrel (AUC 0-24,LN,SS ) (Trial 1) and AUC from time zero to infinity (AUC 0- ) for single doses (AUC 0-,SD ) of furosemide (AUC 0-,furo,SD ) and rosuvastatin (AUC 0-,rosu,SD ) (Trial 2)

December 2014 The JPML denies plaintiffs' request for an MDL

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