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Studies published from January 1, 2002, until June 3, 2013 were included

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All SAEs of death, development of signs of critical illness and severe illness requiring hospitalisation, and AEs as described previously will be reported to the Ethics Committees, the Data and Safety Monitoring Board (DSMB) and to the sponsors of the study within 24 hours of awareness of the event, followed by a final report within 10 days