You are talking about a small number of patients in one of 4 clinical trials that enrolled a total of 4526 patients. All trials hit their endpoints, and the correction does not in anyway reduce their chances of approval as the numbers meet FDA guidelines. Remember that there was a management team shift with the death of Gary Tollefson who helped to write the original protocols. My guess is that this was a detail that slipped through the cracks and was caught recently while reviewing the trial protocols.
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