Statistical Analysis
EVENTS
Patient data captured on e-CRF were collected in a worksheet and/ or directly
from health professionals based on consultations with patients at the clinic for
pertinent statistical analysis, considering that the significance level was
0.05.Descriptive statistics are used to report clinical characteristics, qualitative
variables were reported by absolute frequency (n) and relative frequency
(percentage), and continuous variables are used to obtain mean and standard
deviation. Linearized rates of late AEs are calculated as the total number of
late events (those occurring > 30 days after implant) divided by the total
follow-up time, expressed as a percentage