Figure 2

Flow chart of patients. Overall, 128 cases (nonsurgery, n = 71 [55%]; surgery, n = 57 [45%]) were included in the present analysis cohorts. Initially, 216 patients were screened, 169 patients consented to participate. Randomized cohort was selected by 114 patients and observational cohort was selected by 55 patients. 142 cases were included in the as-treated cohorts, but 14 patients missed visit. The number of patients with registered data are described in the boxes. *One patient was included in both the nonsurgery and surgery cohorts in the as-treated analysis, because the participant allocated in the surgery cohort received nonsurgical treatment for 9 months before undergoing surgery 9 months after enrollment. †Cumulative over time.