You're right, it is a completely different trial.
It's called a pivotal safety and efficacy trial.
It's a well-established requirement for ahieving CE approval.
Even the least intelligent regulatory associate could tell you that. No expertise required.
Feel free to keep misleading yourself and anyone else brain dead or brain washed enough to listen to you whilst I continue to mislead them to the facts.
You're right, it is a completely different trial.It's called a...
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