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Given the possibility that cimetidine may benefit a subset of patients without significant AEs in the context of a small total sample exposed to the drug (n=40, including the RCT), the lack of long-term follow-up data on sufficient numbers of patients, and its potential to interact with other drugs, oral cimetidine was designated as an Option

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Under such circumstances, we would not reopen the initial determination or proceed with the recalculations described in section III.G.7.c.(2).(c) of the CY 2025 PFS proposed rule