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Two subjects in the fasting group withdrew from the trial at the end of the first cycle during the washout period and the fourth cycle, one subject experienced an adverse event (AE) on the second day of dosing in the second cycle, and the investigator judged that withdrawal from the study would be in the best interest of the subject to withdraw from the trial

Furthermore, the long-term safety of brodalumab remains to be determined in the phase three study

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The absence of FDA approval means no verified manufacturing standards, dosing protocols, or safety benchmarks exist for human use