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For each, the following parameters are described: The investigator’s assessment of the causal relationship between the event and the investigational treatment A description of the AE, including its nature, start and stop date, action taken with regards to the investigational treatment, intensity and outcome A statement if the AE fulfils the criteria for an SAE or a SUSAR Intensity is determined according to the following categories: Mild: an AE which is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities Moderate: an AE which is sufficiently discomforting to interfere with everyday activities Severe: an AE which is incapacitating and prevents everyday activities and/or requires therapeutic intervention, i.e
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