The design of the trial, which was a multicenter,
randomized, double-blind, placebo-controlled,
Patients were supplied with a belt outfitted
with two kinetic activity monitors (Kersh Health)
containing high-sensitivity, triaxis accelerometers
(KXUD9-2050, Kionix) (Fig. S1 in the Supplementary
Appendix). Patients were instructed
to wear the accelerometers 24 hours per day except
while bathing or swimming. Each accelerometer
was matched to a patient by means of a
serial number and activated at the time it was
dispensed, providing time- and date-stamped
data synchronized to the study protocol.