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Through sequential trials, "one-dimensional search," reviews and improvements, an acceptable process configuration--a compromise--eventually is reached.
By participating in the HBD process, Abbott was able to evaluate XIENCE V in both Japan and the United States concurrently in the same clinical trial as opposed to conducting separate sequential trials in each country.
The FDA requires that efficacy trials are suitably powered for the primary comparison, and that secondary comparisons and interim analyses in sequential trials are planned and pre-specified.

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