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β€˜Seduced by significance” – the p-value controversy

…acebo), with the added caveat about the assumptions used to calculate the p-value. P-values do not measure the probability that the hypothesis is true, or the probability that the data were produced by random chance alone. Thus, a “significant result” of p<0.05 does not mean that the probability that a result is due to random chance is less than 5%, nor does it mean that there is a 95% probability that the hypothesis is true (e.g. that a drug is s…

Targeting CGRP in migraine

…ect exercise time (Cady et al. Cephalalgia 2017;37(1S):340-341; abstract PO-01-199). Thus, it has been suggested that CGRP antagonists restore normal vascular tone but do not cause abnormal vasoconstriction (Bigal et al. Headache 2013;53:1230-1244; Verheggen et al. Br J Pharmacol 2002;136:120-126). CGRP was initially investigated when migraine was viewed as a primarily vascular disorder. More recent research has focused on the role of CGRP in the…

MS therapeutics: 1 withdrawal, 1 setback

…sued a Refusal to File letter for ozanimod, a second-generation sphingosine-1-phosphate agent selective for the S1P1 and S1P5 receptors. Ozanimod is in development for relapsing MS. The FDA found that the nonclinical and clinical pharmacology sections of the application were insufficient to allow a complete review. Celgene will meet with FDA officials to discuss what additional information is needed, but the setback is expected to significantly de…

DMF: the Canadian MS patient experience

…and resources to MS patients, and attracts about 35,000 visitors per year (www.msology.com). The 21-item survey asked patients currently treated with DMF about their experiences with the drug. All of the Canadian respondents (n=48) were current or recent DMF users. A majority of respondents were female (96%), aged 41 years or older (81%). Forty-percent were previously untreated, and 60% had been on a prior injectable DMT. Most had been taking DMF…

Third failed trial for solanezumab in AD

…rain to the plasma (sink effect). In the EXPEDITION-1 and -2 trials in mild-to-moderate Alzheimer’s disease (n=2052), solanezumab 400 mg IV q4 weeks for 18 months failed to show significant improvement versus placebo in change from baseline to week 80 in the 11-item ADAS-cog scale score; the treatment effect was -0.8 points and -1.3 points in the two trials (Doody et al. N Engl J Med 2014;370:311-321). However, a prespecified secondary analysis of…