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29 where a second trial would be required upon remand.
He said he expected the new cardiovascular trial would be required before approval.
Dr. Bennett-Guerrero emphasized that a large randomized trial would be required before any firm conclusions could be drawn.
Hence a controlled clinical trial would be required in order to adequately address this issue.
Hence, a larger trial would be required to further explore the favourable trend documented here.
A randomized prospective trial would be required to confirm these results.
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However, properly designed treatment trials would be required to prove the benefit of such treatments.
The F.D.A.'s December letter to ImClone suggested that the agency's concerns were more extensive and that new trials would be required.
A spokeswoman for the F.D.A. said the agency had not yet decided whether cardiovascular risk trials would be required for all obesity drugs.
The company, based in Seattle, said it was told by the Food and Drug Administration that it had not adequately demonstrated the safety and clinical benefit of the drug, Bexxar, and that new clinical trials would be required.
That Bristol-Myers made its demands without waiting another few weeks for the meeting suggests it thought that the existing application could not be rescued and that new trials would be required.
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Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com