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however, because of the relatively small number of patients treated, the lack of long-term follow-up data on large numbers of patients, and the potential for serious AEs (e.g., immunosuppression, nephrotoxicity), the Panel judged some uncertainty remains in the balance between benefits and risks/burdens

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Overall, no clinically relevant changes were observed in mean FSV levels or INR in patients receiving odevixibat or placebo during the study

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