Bs2011,
If the BSI body told you to conduct a test and you needed to satisfy a minimum of 20 patients and you needed to achieve A and B.
And you do the study and you submit data for twice that many. Plus you meet and exceed the requirements of A and B.
And then an oversight committee, comes along and says NO you need to do 300 patients and you need to do C and D.
Seriously- if the goal posts have been moved without conveying this information - what does on do.
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