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Other AEs were categorized as dural puncture related (i.e. nausea, vomiting with positional headaches and lightheadedness, N = 3) or skin reactions (redness or swelling, N = 3), which accounted for 20.7% of the total AEs.
All other AEs were categorized as nonserious.
AEs were categorized as non-infectious or infectious.
The majority of outcomes of all AEs were categorized as "resolved" or "improved" (Table 3).
Sepsis, pneumonia, myoclonus and seizure occurring during the advanced critical care period that could not be clearly categorized as typical cooling-related or rewarming-related AEs were categorized as other AEs.
Four of the AEs (12.5%) were categorized as related to the study medication because the affected subjects had taken the formula on an empty stomach (contrary to instructions), and 16 (50%) of the AEs were categorized as possibly related to the study medication, although none resulted in patient withdrawal.
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All other AEs are categorized as non-serious.
All adverse events were categorized as mild.
All other cases were categorized as possible.
AEs were categorized by NCI CTCAE, version 3.0.
AEs were categorized according to the Medical Dictionary for Regulatory Activities.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com