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[DOI] [PubMed] [Google Scholar] 73.Burkhead J.L., Gray L.W., Lutsenko S

If a clinical trial is not suitable: Your healthcare provider may consider whether an early access program may be appropriate Your healthcare provider submits a request on your behalf Your request is reviewed for safety, ethics, and eligibility by the sponsor and/or regulatory authority If approved, you receive the treatment Your healthcare provider will monitor your health and report any safety concerns