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II. Disclaimer of Scientific and Medical Advice: You understand and acknowledge that all users of the NCATS PaVe-GT Site and PaVe GT Resources are responsible for their own choices in drug development, including vector design, preclinical and clinical study design and execution, regulatory strategy, and oversight. All scientific and medical information contained in the PaVe-GT Resources, including but not limited to information in media content, study results, project documents, regulatory submissions, scientific protocols and methods, communications with regulators, publications, presentations, sample templates and curated list of additional resources are for informational purposes only, and are not intended to be a substitute for independent, professional drug development and clinical development judgment or advice. NCATS and/or NIH emphasizes that details, strategies and choices described in the PaVe-GT Resources are not general recommendations, and may be inappropriate, problematic, inefficient, unsafe, or otherwise undesirable for other gene therapy programs or disease indications to adopt, including specific choices and information related to vector design, optimization study design, IND-enabling studies, regulatory approach, dosing, eligibility criteria, and clinical protocols. Users of PaVe-GT Resources must do their own due diligence. Advice on the treatment or care of any patient should always be obtained through consultation with a physician who has examined that patient and is familiar with that patient’s medical history.
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