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After one-third of the study participants have been enrolled and completed follow-up, the DSMBs will review the data and make recommendations concerning continuation, modification or termination of the study due to unexpectedly large beneficial effects or serious side effects and can suggest extension of the trial should the primary outcomes occur less often than anticipated

The effect is metabolic reprogramming at the cellular level

One nuance worth knowing: increased polyamine flux was actually framed as part of the benefit in the original obesity work, because cycling polyamines through synthesis and breakdown burns energy

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For injectable routes, beyond localized reactions like pain or swelling at the injection site, observing for systemic effects becomes paramount