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John joins Amgen from Bristol-Myers Squibb (BMS), where he served as the global head of Clinical Development for marketed products as well as global clinical operations. Earlier roles at BMS included head of worldwide Medical and as a full development team lead in oncology. In these roles, John led a number of innovative changes to the company’s development and medical organizations and practices. He also served as chief medical officer, Europe, head of . Medical and vice president of Cardiovascular Medical. Prior to joining BMS, he was cardiovascular group leader at Pfizer, and was a member of the faculty staff at Kaiser Hospital in San Francisco.

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The number of treatment units (subjects or groups of subjects) assigned to control and treatment groups, affects an RCT's reliability. If the effect of the treatment is small, the number of treatment units in either group may be insufficient for rejecting the null hypothesis in the respective statistical test . The failure to reject the null hypothesis would imply that the treatment shows no statistically significant effect on the treated in a given test . But as the sample size increases, the same RCT may be able to demonstrate a significant effect of the treatment, even if this effect is small. [49]

In behavioural tests of anxiety , a low dose of N
2 O is an effective anxiolytic , and this anti-anxiety effect is associated with enhanced activity of GABA A receptors, as it is partially reversed by benzodiazepine receptor antagonists . Mirroring this, animals that have developed tolerance to the anxiolytic effects of benzodiazepines are partially tolerant to N
2 O . [64] Indeed, in humans given 30% N
2 O , benzodiazepine receptor antagonists reduced the subjective reports of feeling "high", but did not alter psychomotor performance, in human clinical studies. [65]

Results  Fifteen orphan and 12 nonorphan drugs were approved between January 1, 2004, and December 31, 2010. Pivotal trials of orphan drugs had smaller participant numbers (median, 96 [interquartile range {IQR}, 66-152] vs 290 [IQR, 185-394] patients exposed to the drug; P  < .001) and were less likely to be randomized (30% vs 80%; P  = .007). Orphan and nonorphan pivotal trials varied in their blinding ( P  = .04), with orphan trials less likely to be double-blind (4% vs 33%). Primary study outcomes also varied ( P  = .04), with orphan trials more likely to assess disease response (68% vs 27%) rather than overall survival (8% vs 27%). More treated patients had serious adverse events in trials of orphan drugs vs trials of nonorphan drugs (48% vs 36%; odds ratio, ; 95% confidence interval, -; P  = .04).

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In behavioural tests of anxiety , a low dose of N
2 O is an effective anxiolytic , and this anti-anxiety effect is associated with enhanced activity of GABA A receptors, as it is partially reversed by benzodiazepine receptor antagonists . Mirroring this, animals that have developed tolerance to the anxiolytic effects of benzodiazepines are partially tolerant to N
2 O . [64] Indeed, in humans given 30% N
2 O , benzodiazepine receptor antagonists reduced the subjective reports of feeling "high", but did not alter psychomotor performance, in human clinical studies. [65]

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