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The FDA has classified BPC-157 in Category 2 for bulk drug substances, citing possible safety issues in compounding, such as immunogenicity, impurities, and insufficient safety evidence for suggested administration routes

In the intramuscular treatment arm, vitamin B12 will be administered as follows: 1 mg on alternate days in weeks 1 and 2, 1 mg/week in weeks 38,and 1 mg/month in weeks 952

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