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Participants were instructed to continue taking the capsules for six months, maintain a daily pill diary, and return all unused capsules at each visit

doi: 10.1155/2018/2101562

Several factors explain the lack of approval: insufficient clinical trials (no completed Phase 3 trials for most indications), safety concerns (FDA has identified specific adverse events), commercial considerations (patent status affects development investment), regulatory pathway (approval requires specific, rigorous documentation), and competition (Tesamorelin already approved for related indication)

DISCUSSION After two months, the average IL8 concentration decreased significantly in both groups

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