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Based on these findings, Eisai conducted a Phase 2/3 trial (NCT00444613) in Japan to evaluate the safety and efficacy of ultrahigh-dose methylcobalamin injections in 373 adults whose ALS symptoms began up to three years before enrollment

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Category 2 Placement: The FDA placed BPC-157 in Category 2 of the 503A bulk drug substances list, citing "significant safety concerns." This effectively blocked compounding pharmacies from preparing BPC-157 formulations for patients

For older adults, the dose might adjust based on kidney function and health