Senti. Is that enrolled, recruited, or randomized?
Once you have signed the consent form, you could be deemed to have been enrolled, and indeed recruited. But then you might have a change of heart or fail screening. It is only when you have been randomized that you have truly joined the trial.
Except that the last 30-38 joined the trial without being randomized because they could only join treatment!
Confusing isn't it! Lol.
But I do remember the discussions at the time, because the company had stated that 'over 300' or was it 'well over 300' had joined the trial (meaning randomized, I think but maybe not)
We had all those discussions about whether that meant 301 or 310 or any other number. Such fun we had.
The only thing we can say with reasonable certainty, is that after the hold was implemented, any further patients went to treatment.
And we ended up with 331, of which 232 (the correct number for the planned 348) are in treatment.
Regards.
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