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Neurocrine Biosciences' Management Presents At Morgan Stanley Global Healthcare Conference - Transcript

And then it stays blinded – double blinded placebo controlled through month six, where then you see persistence of the effect and looking at other secondary end points at that point in time such as analgesic use. What then the patients do at the end of month six, patients have the choice that every one placebo would be randomized now on to drug, those who are currently on drug can continue in the trial and get six additional months of open-label treatment such that we have one-year of continuous treatment for ICH guidelines or the patients can then stop taking drug and go into a follow-up, a drug free follow-up portion. Those patients that go on to the additional six months a continuous treatment after that six months, so a total of one-year of continuous treatment, then they go into a drug free follow-up period that could last up to one-year at that point of time.

The point for that follow-up period is to obviously look at the recovery of Estradiol levels, which we know from the Phase 2 study in six months a continuous treatment that Estradiol levels come right back up menstruation if it is been perturbed comes back to normal within 30 days for over 90% of the women, and then also to look at bone health.

So, over that one-year of continuous dosing, every three months, the women will be given DXA scans to look at their bone mineral density and then during the untreated portion they will get a bone scan then again at six months to see if there has been any bone loss and we would anticipate minimal bone loss nothing clinically significant, but to see that bone loss come back or utmost it might take 12 months of follow-up.

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