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doi: 10.1038/nature04634

Future research should include appropriately powered cohort studies or randomized controlled trials (RCTs) to: Investigate the prophylactic efficacy of L-carnitine against preterm infant complications [e.g., sepsis, necrotizing enterocolitis (NEC)]

The agency has not evaluated whether the unapproved products subject to the warning letters announced today are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns