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The consent must accurately characterize the compound as an unapproved bulk drug substance (not as an approved drug used off-label), the evidence base and its limitations, known and theoretical risks, alternatives considered, the monitoring plan, and the patients ability to decline or discontinue
Stadler WM, Margolin K, Ferber S, McCulloch W, Thompson JA
The staff/team at TRTMD are absolutely amazing in these knowledge, care and support
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