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Any event (excluding any event that is clearly due to disease progression as defined in the protocol) which is: Associated with a study patients death, Associated with in patient hospitalisation or prolonged hospitalisation Life threatening to a study patient associated with a severe or permanent disability of a study patient a congenital abnormality/birth defect or significant other reason including cases of newly diagnosed cancer AND which is considered to have a reasonable causal relationship with the study drug (suspected) and the nature of severity of which are inconsistent with the available product information (unexpected)

Chen X, Zhou Y, Wu D, Shu C, Wu R, Li S, et al

Patience and consistency are key to achieving optimal results with BPC-157 therapy

[10] [11] The change in protonation state is gradual