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The propensity score was constructed from age at the index date (continuous), sex, race, region, number of RMS relapses in the preindex period (0, 1, 2+), prior DMT in the preindex period, RMS disability in the preindex period, Deyo-Charlson comorbidity index (DCCI) in the preindex period (continuous), and Psychiatric Diagnosis Group index in the preindex period (continuous)

While AOD 9604 is considered to be a GRAS treatment

B12 is a water-soluble vitamin

So the agency can't even write a quality standard for it because it can't say what "it" is

Understanding the Growth Hormone Fragment 176-191 The specific sequence of amino acids in AOD-9604 is based on the C-terminal end of human growth hormone, specifically amino acids 176 through 191

PLoS One 8 , e77284 (2013)