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Additionally, since our data are derived from a subpopulation of a study designed to evaluate CV outcomes and our population of interest was not prespecified by the initial LIGHT study protocol, the integrity of the randomization can no longer be assumed, and the results should therefore be interpreted with caution

Heres the context: serious adverse events are rare and typically associated with pre-existing conditions

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These symptoms arent prominently featured in the current prescribing information, Sehgal said