Results
Of the 72 randomized participants (median age, 39.5; 27 [37.5%] male participants), 72 (100.0%) completed the trial. The analysis sets of full analysis set, per-protocol set, and safety analysis set included 72 cases (32 cases in Center A, 16 cases in Center B, and 24 cases in Center C). The consistency, completion rate, and first success rate were 100% (