Patients received 1 of 2 dosing regimens of oral ALKS 5461 or placebo for cure period of a month. The study utilized a sequential parallel comparison design, a design developed a decade ago by Drs. Fava and Schoenfeld at Massachusetts General Hospital and now widely employed in clinical trials. The principal endpoint of the analysis was the change from baseline in depressive symptoms over a four-week treatment period, as measured by the HAM-D17. Secondary endpoints included additional analyses of individual responses predicated on HAM-D17, CGI-S and MADRS scores.Hormonal studies which were performed at the time of diagnosis showed the anticipated high gonadotropin levels and low estradiol levels, with follicle-stimulating hormone levels of more than 45 mIU per milliliter , luteinizing hormone degrees of a lot more than 18 mIU per milliliter , and estradiol levels of significantly less than 22 pg per milliliter . We ruled out the presence of autoantibodies in every four sisters. We performed genetic screening on samples attained from the four sisters with the disorder to eliminate known genetic causes of premature ovarian failure. The results of the testing showed a standard 46,XX karyotype no premutations in the gene encoding fragile X mental retardation 1 .