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. 2022 Jan 8;79(3):251–260. doi: 10.1001/jamaneurol.2021.4998

Figure 1. CONSORT Diagram.

Figure 1.

AE indicates adverse event.

aCOVID-19 resulted in 2 missed 24-month visits in the open-loop group.

bAll randomized patients (67 in the closed-loop group and 67 in the open-loop group) were included in the analysis of the primary outcome, visual analog scale pain, using a last value carried forward approach to account for missing data. Patients who completed the 24-month visit (50 in the closed-loop group and 42 in the open-loop group) were included in the analysis of secondary outcomes.