Combined-Indications Significance Level of Multiple Related Indications Developed Simultaneously

Yuan, JC; Zhu, RA; Jia, D; Palm, U; Koch, G

Yuan, JC (reprint author), Allergan Pharmaceut Inc, 2525 Dupont Dr,M12-2D, Irvine, CA 92612 USA.

THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 0; ():

Abstract

Background: Typically, regulatory requirements include 2 confirmatory studies, each at a 1-sided .025 significance level, for a medicine to be approve......

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