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The safety data available derive from Phase 2 clinical trials (Jastreboff et al., NEJM, 2023), which, whilst informative, represent a relatively limited population and duration of follow-up compared to post-marketing surveillance

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For planned comparisons against a single treatment of interest, Dunnetts test was applied using the relevant reference group (PG-102 for preclinical experiments, placebo for clinical datasets)

Once filled, enrollment pauses until the next cycle