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To rule out inferiority, the FDA required CVOTs to show an upper boundary risk ratio of 1.3 (post approval), utilizing a two-sided 95% confidence interval (CI), for major adverse cardiovascular events (MACE) [55]

"We need to have multiple agencies and regulatory bodies sitting together with health professionals, as well as tying in big names, celebrities and credible influencers to talk about the dangers of melanotan, the dangers of skin cancers, particularly targeting vulnerable young people." Australia's medicines regulator, the Therapeutic Goods Administration (TGA), has warned unregulated peptides pose a "significant" public health risk

The choice between oral and injectable formulations is typically down to individual factors and preferences