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Data on one do not automatically transfer to the other

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A serious AE was defined as an AE resulting in any of the following: death, life-threatening experience, in-patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity or a congenital anomaly/birth defect, or important medical event that might not be immediately life-threatening or result in death or hospitalization but might jeopardize the patient or might require intervention to prevent one of the other outcomes listed in the definition above

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