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b Major bleeding was defined as clinically overt: and/or contributing to death and/or in a critical organ including intracranial, retroperitoneal, intraocular, spinal, pericardial, or adrenal gland and/or associated with a fall in hemoglobin level greater than or equal to 2 g/dL and/or leading to a transfusion greater than or equal to 2 units of packed red blood cells or whole blood

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Reconstitution of BPC-157 for research purposes must be performed using sterile techniques to avoid contamination

The amount of drug reaches the circulation, the effects are stronger

For each, the documentation must specify the acute event and the blood loss volume or clinical signs of hemodynamic instability