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Therefore, we do not believe it is appropriate to bundle the weekly and monthly formulations into a single bundled payment since, unlike the drug Sublocade, the Brixadi formulations have different payment limits, and pricing them under the same bundle would not adequately represent the average costs incurred in furnishing these different formulations in an OTP setting

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Although in vitro assays are not able to replace all conventional animal bioassays, they are increasingly seen as alternatives to animal testing of drugs and chemicals, in the European Union, the United States, and elsewhere (Hfer et al