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We measured the primary outcome objectively using a validated electronic medication monitor [ 13] that allows a day-by-day description of adherence as well as providing summary measures.
BP was measured using a validated ambulatory BP monitor (Oscar-2; SunTech Medical) at 15-min intervals during 2 hr of exposure and at 30-min intervals before and after filtered-air and CAP exposure.
After 5 minutes of rest, BP in the brachial artery was measured using a validated digital BP monitor (Dinamap® PROCARE 300, GE Healthcare, Buckinghamshire, UK) [ 24] in the sitting position with an appropriately sized cuff and table support for the measured arm.
Clinic BP was assessed at the screening visit and at each office visit using a validated digital BP monitor (HEM-907X, Omron Healthcare, Inc., Bannockburn, IL) and according to standards set by the American Heart Association AHAA) [ 23]. 24 hr ambulatory BP was assessed at baseline and after 6 months (Spacelabs Healthcare, Issaquah, WA) with an appropriately sized cuff.
To test the predictability of our findings from animal studies, we measured VO2max and 10-day baseline physical activity in non-exercising people using a validated Physical Activity Monitoring System [11].
Core body temperature (assessed using a validated telemetric physiological monitoring system) was a key safety endpoint.
Trained researchers measured blood pressure and pulse rate at the participants' homes using a validated automatic blood pressure monitor (Omron HEM-7301-IT HEM-7301-IT HEM-7301-ITropriAmsterdamed cuff.
Blood pressure was measured while the subject was in a sitting position using a validated automated blood pressure monitor (ES-H55; Terumo, Tokyo, Japan).
To our knowledge, this is the second randomised crossover trial to examine the effects of SW intervention on objectively measured PA [ 15] and the first using a validated waist mounted accelerometer monitor.
BP and resting heart rate were recorded after five minutes of rest in a sitting position [ 14], using a validated and calibrated electronic BP monitor (Omron M5-I).
Ideally severity of withdrawal symptoms during the detoxification would be monitored using a validated research tool.
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