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In explaining its decision, the agency flagged concerns about complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization, the potential for aggregation and a lack of human safety data

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Immunostimulants like Toll-like receptor (TLR) agonists, damage-associated molecular patterns, and pathogen-associated molecular patterns (PAMPs), will trigger antigen-presenting cells (APCs) to boost antigen presentation and co-stimulatory signaling leading to adaptive immune enhancement

To mitigate such a decline, the patient should be adequately assessed and treated by a dedicated team of specialists, which should also include trained psychosexologists and/or an expert in sexual medicine