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This Complication Review Board decides also if the complication is related to the operative procedure, as expressed by the following statements: not related, unlikely related, possibly related, probably related or definitely related.
Adverse events were assessed for causality as probably related, possibly related, unlikely to be related or not related to study medications.
The relationship of any adverse event to mobilisation therapy will be assessed by the investigator and qualified by association (not related, unlikely, possibly, probably or definitely related) and intensity of the effect (mild, moderate or severe).
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The remainder of adverse events were mild (132/176 events, 75%) and not related or unlikely related to vaccine (165/176 events, 94%).
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The other deaths were considered not related or unlikely to be related to the study medications.
All GI bleeding events in fidaxomicin subjects were deemed not related or unlikely related to the drug by the investigators.
The fact that neither musculoskletal symptoms nor genetic DNA-based research were the primary objectives of the study makes interest related participation unlikely.
A causal association between sc IFN β-1a treatment and TMA/TTP-HUS was suspected in 67.0% (n = 61/91) of cases, not suspected/not related or unlikely in 13.2% (n = 12/91), not reported/unknown in 18.7% (n = 17/91), and "not assessable" in one case.
Nine of the 10 deaths were deemed "unlikely related" or "not related" to clobazam by investigators.
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CEO of Professional Science Editing for Scientists @ prosciediting.com