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Patients assigned bimagrumab in the clinical trial received IV infusions of the drug at weeks 4, 16, 28 and 40

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The title for this section varied, but the placement of this language at the end of a warning letter, similar to recommendations to engage a third-party cGMP expert or calling out specific concerns surrounding data integrity, shows the agencys desire to clearly communicate the significance of this message, including the need for effective quality agreements