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This withdrawal decision follows talks with the U.S. Food and Drug Administration or FDA on its proposed process for the review of interim data. Sanofi believes that potential public disclosure of early interim data, even with safeguards, could potentially compromise the integrity of the ongoing ELIXA trial. Sanofi said it's decision is unrelated to safety issues or deficiencies in the NDA.
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On that score, "One Direction: This Is Us" does an excellent job showcasing the five young lads at the center of all that hormonal chaos - and while Cowell and company would clearly like to evoke another pretty popular British mop-topped foursome (the Beatles are namechecked a couple times), One Direction is stirring up a madness all its own.
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