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USA 94 , 1386813872 (1997)

Wang JF, Pu X, Zhang X, Chen K, Xi Y, Wang J, Mao X, Zhang J, Heymach JV, Antonoff MB, Hofstetter WL, Mehran RJ, Rice DC , Roth JA, Sepesi B, Swisher SG, Vaporciyan AA, Walsh GL, Meng QH, Shaw KR, Eterovic AK, Fang B

But it has not been ruled out, and the FDA's briefing documents noted it as an uncharacterized risk requiring further investigation before any approval