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Many of these patients are prescribed immunosuppressant medications that place them at higher risk of complications

If results are promising, the programme moves to Phase 3: larger, global, randomised trials involving, dependent on the indication hundreds to sometimes even thousands of participants, designed to confirm efficacy and build a robust safety profile

Once opened, a sterile water single-use vial should be used immediately and then thrown away any leftover is not saved

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If the product is marketed or meets federal standards to qualify as a drug, but is not FDA-approved, it cannot be sold legally, Cleland said