Sea otters Enhydra Iutris were re-introduced into coastal waters of British Columbia, Canada, in 1969-1972, after being hunted to extinction In the previous 2 centuries. In 1979, we visited an area where 55 individuals had been seen in 1978, and we made subtidal observations of the abundance and distribution of red sea urchins, other grazers, and kelps. Earlier observations, made in the area before sea otters were re-introduced, confirmed that changes have taken place in subtidal communities since the re-introduction. Where sea otters had been observed feeding, sea urchins Strongylocentrotus franciscanus were scarce and restricted to crevices or beneath boulders, other grazers were scarce, and kelps colonized the bottom to 10-m depths. The algal communities in these areas appeared to be simple downward extensions of sublittoral fringe communities. Where sea otters had not fed, kelps were limited to shallow water by abundant sea urchins. The observed differences between the 2 types of areas are concluded to have been caused by early ellmlnation of sea urchins by sea otters, as reported in Alaska and California. From the pattern of sea urchin abundance in the general area of the transplant, we were able to delineate the feeding range of this small population of sea otters.

Study question: Can asoprisnil, a selective progesterone receptor modulator, provide clinically meaningful improvements in heavy menstrual bleeding (HMB) associated with uterine fibroids with an acceptable safety profile? Summary answer: Uninterrupted treatment with asoprisnil for 12 months effectively controlled HMB and reduced fibroid and uterine volume with few adverse events. What is known already: In a 3-month study, asoprisnil (5, 10, and 25 mg) suppressed uterine bleeding, reduced fibroid and uterine volume, and improved hematological parameters in a dosedependent manner. Study design, size, duration: In two phase 3, double-blind, randomized, placebo-controlled, multicenter studies, women received oral asoprisnil 10 mg, asoprisnil 25 mg, or placebo (2:2:1) once daily for up to 12 months. Participants/materials, setting, methods: Premenopausal women ≥18 years of age in North America with HMB associated with uterine fibroids were included (N=907). The primary efficacy endpoint was the percentage of women who met all 3 predefined criteria at 12 months, or final month for subjects who prematurely discontinued: (1) ≥50% reduction in monthly blood loss (MBL) by menstrual pictogram, (2) hemoglobin concentration ≥11 g/dL or an increase of ≥1 g/dL, and (3) no interventional therapy for uterine fibroids. Secondary efficacy endpoints included changes in other menstrual bleeding parameters, volume of the largest fibroids, uterine volume, and health-related quality of life (HRQL). Main results and the role of chance: In all, 90% and 93% of women in the asoprisnil 10 mg and 25 mg groups, respectively, and 35% of women in the placebo group met the primary endpoint (P<0.001). Similar results were observed at month 6 (P<0.001). The percentage of

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Aims: This 12-week, open-label, primary care study (NCT02195817) evaluated the efficacy and safety of nalmefene, taken as needed, to reduce alcohol consumption in adults with a diagnosis of alcohol dependence and drinking at least at high drinking risk levels (DRL, > 60 g/day for men, > 40 g/day for women). Methods: Following the Screening Visit, patients recorded their daily alcohol consumption for 2 weeks. Patients were then categorised by their self-reported drinking levels; those who maintained at least a high DRL in the 2-week period were included in Cohort-A, and those who reduced their alcohol consumption below high DRL were included in Cohort-B. Cohort-A received simple psychosocial interventions and were supplied with nalmefene 18 mg to be taken on days when they perceived a risk of drinking alcohol. Patients in Cohort-B received a simple psychosocial intervention and were treated per normal practice. Results: Of the 378 enrolled patients, 330 were included in Cohort-A and 48 in Cohort-B. For patients in Cohort-A, the mean change from screening to Week-12 in the number of heavy drinking days/month was –13.1 days/month (95% CI –14.4 to –11.9, p < 0.0001). Overall, 55% of patients reduced their DRL by ≥2 risk levels and 44% of patients reduced to a low DRL. The most common adverse events were nausea (18.3%) and dizziness (17.7%). Patients in Cohort-B maintained their lower level alcohol consumption at the 12-week follow-up. Conclusions: Patients with alcohol dependence treated in primary care with nalmefene, taken as needed, in conjunction with simple psychosocial support, significantly reduced their alcohol consumption. Treatment was well tolerated.

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