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Participants will be assessed for safety at 30, 90 and 180 days from treatment commencement, and at 14 days following treatment cessation

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doi: 10.1016/0271-5317(95)92586-9

References Richie, J.P., Nichenametla, S., Neidig, W., Calcagnotto, A., Haley, J.S., Schell, T.D., and Muscat, J.E