COVID-19
Measures were taken to mitigate risks caused by the COVID-19 pandemic and to circumvent issues related to site closures. Flexibility in site-visit scheduling was allowed, and all resulting protocol deviations had to be reported under the specific category of COVID-19-associated deviations. When in-person visits were not possible, safety surveillance and selected clinical assessments (CDR, ADCS-ADL, ISLT, Category Fluency Test and Letter Fluency Test from the Delis–Kaplan Executive Function System, and Columbia Suicide Severity Rating Scale) were allowed to be performed by telephone. Infusions at home or alternative sites and home-nursing options were permitted in some instances. Visits or procedures missed due to reasons related to the COVID-19 pandemic had to be completed as soon as possible and reported as delayed or missed with appropriate reasons provided.