Study endpoints
ADVERSE EVENTS
Long-term safety was compared between RDN and sham control groups through 36 months using a composite endpoint of major adverse events. Long-term efficacy was evaluated from baseline to 36 months. Nighttime (1:00–6:00 AM) and morning (7:00–9:00 AM) BPs were separately calculated from the average of BPs. Morning BP parameters were defined as follows: average morning SBP (average of morning SBPs), moving peak morning SBP (highest 1 h moving average of 3 consecutive SBPs over the morning period) and minimum (lowest recorded value) and maximum (highest recorded value during the morning interval) morning SBP. Nighttime BP parameters were similarly defined as follows: average nighttime SBP (average of nighttime interval SBPs), average peak night-time SBP (average of the 3 highest measurements over the nighttime interval) and minimum (lowest recorded value) and maximum (highest recorded value during the nighttime interval) nighttime SBP.