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Studies often have pre-specified committees that deal with any problems that come up.
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Also, in some cases, like Thailand, some of the new expenditure programs aimed at employment creation will end at a pre-specified date.
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Avastin met the pre-specified endpoints in all three of the trials considered (making it four in a row, including the original trial that supported approval).
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Within the study, participants were asked to quickly scan a row of digits and cross out consecutive numbers that add to a pre-specified total (for example, any two numbers that total 3).
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Lilly, however, noted that a pre-specified secondary analysis of pooled data showed statistically significant slowing of cognitive decline in patients with mild-to-moderate disease who were treated with its solanezumab compound.
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And pre-specified secondary subgroup analyses of pooled data across both studies showed a statistically significant slowing of cognitive decline in patients with mild disease, but not in those with moderate disease.
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But the standard in medicine is usually to include the drop-outs, raising the bar for new drugs, and this was the analysis pre-specified in the SHARP protocola nd the one Merck presented.
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Such manufacturability implies that repeated fabrication of artefacts is possible to produce electronic, optical, magnetic or other properties with a high and highly reproducible yield within a tight tolerance of a pre-specified performance.
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But the approval may not be a sure thing, according to Daniel Petrylak, an oncologist at Columbia University Medical Center, because Dendreon's studies did not meet their main pre-specified goal: a slowing of tumor progression.
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