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This trial is registered with NCT01319682.
FDA device/drug status: Not applicable.
Author disclosures: K-TK: Nothing to disclose. D-CC: Nothing to disclose. J-KS: Nothing to disclose. Y-BK: Nothing to disclose. HK: Nothing to disclose. K-SS: Nothing to disclose. G-JC: Nothing to disclose.
K-TK and D-CC contributed equally to this work.