The five observational studies and the Xu meta-analysis were discussed at a joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on September 17, 2014. Based on these findings, the advisory committee members were in general agreement that the signal of cardiovascular risk is weak and that only a prospective, well-controlled clinical trial could determine whether testosterone causes cardiovascular harm. The Corona study was recently published and could not be reviewed in time to be presented at the Advisory Committee meeting; however, we have reviewed the study and factored its findings into our overall assessment.
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