Figure 1.

Enrollment and follow‐up. *Patients were excluded from the modified intention‐to‐treat analysis because no effectiveness assessments were available after the baseline visit. ^†Patients were excluded from the per‐protocol analysis because they either did not meet eligibility criteria or did not complete the trial before the planned visits with complete test results in accordance with the protocol. Some patients were excluded from the per‐protocol analysis for more than one reason but were included in only one exclusion category