The study is conducted in severe hemophilia A patients (įor Urgent Translation: Please email me at or text me at WhatsApp.
This protocol follows closely the requirements of the EMA guidance on the clinical investigation of recombinant and human plasma-derived FVIII products. Korean to English: Medical:Pharmaceuticals II In any presentations of the results of this study or in publications, the subjects’ identity will remain confidential. Monitors, auditors, and other authorized agents of XXXXXX and/or its designee, the IEC(s)/IRB(s) approving this research, and the Food and Drug Administration, as well as that of any other applicable agency(ies), will be granted direct access to the study subjects’ original medical records for verification of clinical study procedures and/or data, without violating the confidentiality of the subjects to the extent permitted by the law and regulations. English to Korean: Clinical Trial Protocol
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