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FDA device/drug status: Not applicable.
Author disclosures: QC: Nothing to disclose. FFS: Nothing to disclose. LBM: Nothing to disclose. LML: Nothing to disclose. YMS: Nothing to disclose.
Conflicts of interest and source of funding: No funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.
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