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Bakaeen F, Rice D, Correa AM, Walsh GL, Vaporciyan AA, Putnam JB, Swisher SG , Roth JA, Huh J, Chu D, Smythe WR

Requirements for reporting adverse events to research ethics committees can vary between nations [16] but international guidance recommends that unexpected serious adverse events related to the intervention (SUSARs) be promptly reported [11]