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doi: 10.1016/j.neures.2006.04.008 73 BendottiGMontefuscoLLunatiMEUsuelliVPastoreILazzaroniEet al

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If TRIUMPH-1 or TRIUMPH-2 reveal a new safety concern not seen in smaller trials, the FDA could require additional studies

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These statements are based on the companys current beliefs and expectations

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