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Feng, 2017

Phase II clinical trials for inflammatory bowel disease reported no toxicity or adverse events in treated patients, though detailed safety data from these trials have not been published in peer-reviewed literature

Comment: A commenter mentioned our proposed regulation text edits and noted that the changes discussed in the preamble did not align with what was included in the regulation text at the end of the proposed rule and suggested that there may have been an inadvertent drafting error

Aliquot and store reconstituted solutions at 20 C or below to minimise degradation