OK, so I emailed Leslie.My question was:
' .... Of the 14 patients enrolled how many of the 4 NOT evaluable patients were in fact the additional enrollments referred to in the ann of 11-Sep-2018? ....'
The relevant part of Leslie's prompt reply contained:
' .... your question, the patients are considered non evaluable when they couldn’t make the day 56 scans and it was across all the dose levels. Their data was collected for other study parameters .... '
Although not directly answering my question it is pretty clear to me that the 4 not evaluable patients were NOT part of the additional recruitments. Further, it is now unclear to me whether the 14 patients referred to included these additional patients or not (assuming any such patients were, indeed, ever enrolled.)
Therefore, I humbly apologise for previously insisting that those 4 non evaluable patients were 'additional' (as in the sense of the 11-09-2018 ann).
My nett conclusion is that 14 patients were enrolled to be 'potentially' evaluated for top line results, of which 4 did not last the 56 day journey (for whatever reason), leaving 10 to meet the evaluation criteria. It is for others wiser than I to attach significance, if any, to this apparent fact.
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