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Table 2 Assessment of causality and severity of adverse events

From: Acupuncture or auricular electro-acupuncture as adjuncts to lifestyle interventions for weight management in PCOS: protocol for a randomised controlled feasibility study

Assessment of causalityAssessment of severity
Unrelated: where an event is not considered to be related to the study interventionMild: an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with every day activities.
Possibly: although a relationship to the study intervention cannot be completely ruled out, the nature of the event, the underlying disease, concomitant medication or temporal relationship make other explanations possible.Moderate: an event that is sufficiently discomforting to interfere with normal everyday activities.
Probably: the temporal relationship and absence of a more likely explanation suggest the event could be related to the study intervention.Severe: an event that prevents normal everyday activities
Definitely: The known effects of the study intervention or its physiological mechanisms suggest that study intervention is the most likely cause.