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Subjects in the single-arm group will receive the study device.
The study device was repetitively applied by each patient to the bilateral periorbital areas for 5 minutes.
The APOLLO Trial is a multi-center, global, prospective, randomized, interventional, pre-market trial with two subject groups: the randomized group will be randomized on 1 1 basis to either the study device or to conventional mitral valve surgery.
Tape and TMD securement resulted in an unscheduled catheter restart rate of 25%; the study device resulted in an unscheduled catheter restart rate of 12.8%.
A clinical presentation of the use as well as the components of the study device is depicted in Figure 1.
Subjects received a total of two nVNS treatments with the study device, 30 min apart and each lasting 60 s.
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S.S. wrote the software of the study devices and enabled the technical side of the data collection.
Four other serious adverse events occurred in the CSII group that were unrelated to the study devices or the protocol.
There were no statistically significant differences 5-FUU vs CH-SS) in local site infections (1.4% vs 0.9%), CRBSI (0% vs 2.8%), and the rate of adverse events related to the study devices (3.4% vs 3.5%).
After a brief description of the studied device the scaling up effect was checked.
(a) Simplified schematic of the studied device consisting of an InAs QD (pyramid) between emitter (E, blue) and collector (C, red) and the equivalent detection circuit.
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