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This determination was based on chronic toxicity studies, genotoxicity studies, and human clinical trial safety data
Notable is that these patients did not have type 2 diabetes or a glycated hemoglobin level of 6.5% or higher or treatment with any glucose-lowering medication or GLP-1 receptor agonist within the previous 90 days at screening, e.g
[4] [5] The three primary subcutaneous injection sites used for comparable licensed therapies (such as semaglutide and tirzepatide, as described in their UK Summary of Product Characteristics) are: Abdomen the area around the stomach, avoiding the area immediately around the navel Front (anterolateral) thigh the outer-front portion of the upper thigh Upper arms the outer area of the upper arm, typically requiring assistance from another person for self-administration The abdomen is generally considered the most accessible and commonly used site, as it offers a relatively large surface area of subcutaneous fat and is straightforward to self-administer
Extended wakefulness, exposure to cold, excessive noise).
