Characteristics of the participants
ADVERSE EVENTS
Eight subjects (all male, mean age: 44.8 ± 15.8 years) were enrolled and randomized to the 2 groups (n = 4 for each group). All the subjects met the inclusion criteria, strictly followed the protocol and were assessed with both devices. Therefore, all participants were treated per protocol and belonged to the intention to treat set. No adverse events were reported by any of the participants.The characteristics of the participants are summarized in 