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Both medicines are unlicensed in the UK, meaning they cannot be prescribed through standard NHS or private prescribing routes

The supplemental approval was granted based on data from the Phase III EMBARK trial, which studied Xtandi plus leuprolide, placebo plus leuprolide (a synthetic hormone regulator) and Xtandi as a monotherapy

The renal impairment study excluded participants who required dialysis and while renal clearance is a focus of this study, this can be seen as a limitation

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