| Grade 1 | Mild; asymptomatic or mild symptoms; clinical signs or diagnostic observations only; intervention not indicated. |
| Grade 2 | Moderate; outpatient or non‐invasive intervention indicated; moderate limitation of Activities of Daily Living (ADL). |
| Grade 3 | Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; significantly limiting Activities of Daily Living (ADL). |
| Grade 4 | Life‐threatening consequences; urgent interventions indicated |
| Grade 5 | Death related to AE Death can be defined as either euthanasia or natural death, according to the investigators' discretion. |
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