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The Tobago Cays in the Grenadines showcase a variety of colorful hard and soft corals, fans and whips as well as being home to green turtles, nurse sharks and eagle rays that swim in the calm, azure-hued waters. Horseshoe Reef, frequently described as a kaleidoscope of colors, protects four of the five uninhabited islands that are all part of Tobago Cays Marine Park. This treasured area remains under the watchful eye of rangers who ensure the coral-reef system continues to thrive, with lots of tropical fish found in waters only five to 12-feet deep. If you’ve got your heart set on turtles, the protected grassy area right outside the beach (anchor) of Baradel is the place to go.
Little Cayman is just ten miles long and a mile wide but offers one of the premier snorkeling diving locations in the world. Its tiny population of less than 200, along with scant development, mean virtually no human-caused damage to its reefs, while its marine park status ensures continued protection of one of the earth’s most magnificent underwater attractions, Bloody Bay, regarded as the most breathtaking drop-off in the Caribbean. Snorkelers here have the rare opportunity to swim over a coral cliff, experiencing one of the most amazing undersea panoramas on the planet. While floating in the translucent waters at Three Fathom Wall, you’ll see numerous fish swimming about the bottom, roughly 18 feet below, and you may also notice many sets of curious eyes observing your journey, including the ever-fascinating hawksbill turtle. The walls of Bloody Bay are teeming with healthy creatures, including tangles of rope sponges, gigantic barrel sponges, and webs of soft corals.
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Mean change in weight from baseline to day 28 was similar in all treatment arms (Figure 3). Median change in weight from baseline to day 28 was 0/9 kg (range, −36 to 11 kg) for 42 mg of lumateperone, 0/6 kg (range, −12 to 13 kg) for 28 mg of lumateperone, and 0/7 kg (range, −12 to 16) for placebo. Weight changes of 7% or greater and shifts in body mass index from overweight to obese were infrequent and similar among groups (eFigure in Supplement 2). There were no significant mean changes in metabolic parameters from baseline to day 28 compared with placebo (Figure 3).
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Dr Tamminga reported being a consultant for Intra-Cellular Therapies during the conduct of the study. Drs Mates and Vanover reported receiving personal fees from Intra-Cellular Therapies during the conduct of the study. No other disclosures were reported.
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Interaction analyses suggested consistent treatment effects for demographic subgroups of race (black vs not black), ethnicity (Hispanic/Latino vs not Hispanic/Latino), age (≤40 vs >40 years), and sex for the comparison of 42 mg of lumateperone vs placebo in PANSS total score. A responder analysis indicated that 54 patients (36/5%) treated with 42 mg of lumateperone, 53 (36/3%) treated with 28 mg of lumateperone, and 36 placebo-treated patients (25/5%) had 30% or greater improvement in PANSS total score (eTable 4 in Supplement 2).
All prespecified efficacy analyses were performed for a prespecified modified intent-to-treat analysis set, which includes all randomized patients who received at least 1 dose of study medication and had a valid baseline and at least 1 valid postdose assessment. See additional statistical analysis information in the eMethods in Supplement 2.
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Efficacy and Safety of Lumateperone for Treatment of Schizophrenia: A Randomized Clinical Trial
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Analysis of covariance last observation carried forward was used. P values are nominal and unadjusted for multiplicity.
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Patients were required to have a score of 4 or higher, indicating moderate to severe disease severity, on the Clinical Global Impression–Severity of Illness (CGI-S)16 at screening and baseline. Severity of illness was confirmed at baseline by a Positive and Negative Syndrome Scale (PANSS)17 total score of 70 or higher, indicating moderate to extreme symptoms of schizophrenia. Patients had to have a previous response to antipsychotic therapy. Additional inclusion and exclusion criteria are given in the eMethods in Supplement 2.
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Design, Setting, and Participants This randomized, double-blind, placebo-controlled, phase 3 clinical trial was conducted from November 13, 2021, to July 20, 2021, with data analyses performed from August 13 to September 15, 2021. Patients with schizophrenia who were aged 18 to 60 years and were experiencing an acute exacerbation of psychosis were enrolled from 12 clinical sites in the United States.
Antigua is considered a snorkeler’s paradise, with its powdery soft white sands, warm clear waters, natural coral reefs, shipwrecks, underwater walls and valleys home to all sorts of brightly colored tropical fish. In many areas, there is practically no current, making it ideal for first-time snorkelers and children. At Paradise Reef, just north of Dickenson Bay, you’ll find a one-mile-long coral reef that’s part of an underwater park, home to The Wreck of the Andes, a merchant ship that sank over a century ago. As the ship sits in depths of just 30 feet, it can be explored by divers as well as snorkelers.
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On their website they say it better than I can: “GIMP is a cross-platform image editor available for GNU/Linux, OS X, Windows and more operating systems. It is free software, you can change its source code and distribute your changes. Whether you are a graphic designer, photographer, illustrator, or scientist, GIMP provides you with sophisticated tools to get your job done.
It’s always great to see a company support multiple operating systems. But giving users the ability to edit videos right in their own browsers is far better.
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No clinically meaningful changes from baseline or differences observed in physical examination results, vital signs, or ECG findings were found between the lumateperone and placebo groups. One patient in the placebo group (before treatment) and 1 patient in the 28 mg of lumateperone group (before and after treatment) had a corrected QT interval by Fredericia greater than 450 milliseconds. No patients had a corrected QT interval by Fredericia greater than 500 milliseconds or a change greater than 60 milliseconds from baseline.
Importance Individuals living with schizophrenia are affected by cardiometabolic, endocrine, and motor adverse effects of current antipsychotic medications. Lumateperone is a serotonin, dopamine, and glutamate modulator with the potential to treat schizophrenia with few adverse effects.
First MB, Williams JBW, Spitzer RL, Gibbon M. Structured clinical interview for DSM-IV-TR Axis I disorders, clinical trials version (SCID-CT). New York: Biometrics Research, New York State Psychiatric Institute; 2007.
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First MB, Williams JB, Karg RS, Spitzer RL. Structured Clinical Interview for DSM-5 Disorders—Clinical Trials Version (SCID-5-CT, Modified for ITI-007-301). Arlington, VA: American Psychiatric Association; 2021.
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Safety results were summarized descriptively by treatment group and visit (when applicable). The incidences of clinical laboratory tests, vital signs, and ECG results that met predefined markedly abnormal criteria were summarized.
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