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What regulatory guidelines apply to (3S)-3-[3-Bromo-5-(2-methyl-2-propanyl)phenyl]-3-[(N-{3-hydroxy-5-[(5-hydroxy-1,4,5,6-tetrahydro-2-pyrimidinyl)amino]benzoyl}glycyl)amino]propanoic acid (CAS: 1564286-55-0)?
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