Disagree with your analysis, when considering the discrepancy between US and AUS vehicles.
When reviewing the AUS data alone, the primary endpoint data is statistically significant for inflammatory lesions.
IF there had been no discrepancy, your analysis would stand.
Unfortunately, the data is the data and BOT cannot discredit the US results (at this stage anyway), however they have clearly undertaken a root cause analysis and put a plan in motion to resolve for phase 3.
Cheers,
Sven
BOT 1503 Study Analysis, page-6
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