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While TEAEs, grade 3 or higher TEAEs, TEAEs associated with fatal outcome, and serious adverse events (SAEs) appeared similar to placebo, there was a higher rate of drug discontinuation (20.4% versus 8.6%), dose interruption (34.0% versus 20.1%), and dose reduction (18.9% versus 6.3%) due to TEAEs for VANFLYTA compared to placebo and we would appreciate additional information regarding these differences

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It is the rare drug (some types of tetracycline) that become toxic if outdated