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This approval was based on two pivotal Phase 3 randomized controlled trials a regulatory pedigree that makes tesamorelin one of the most clinically documented peptides in the GH-axis category

It was prepared as a peptide with 99% (HPLC) purity (1-des-Gly peptide was the main impurity

Product purity is unverified

The lobular distribution of P450a staining by immunohistochemistry was identical between the two stocks

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