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In the prespecified intent-to-treat analysis they were counted in the OMT group, whereas an as-treated analysis might well have shown statistically significant reductions in death and MI in the PCI group.
Using multiple office visits to identify ambulatory cases in an as-treated analysis would have required the introduction of immortal person time into the design, (30) hence those potential cases did not meet the study outcome definition.
The researchers combined the outcome data from both cohorts in an as-treated analysis.
However, this was significant using an as-treated analysis (p=0.
Nevertheless, the as-treated analysis of 654 patients in the combined randomized and observational cohorts showed that the surgery group had a mean 19.