Procedure
fatigue
JETLAG, ADVERSE EVENT, ADVERSE EVENTS
One week prior to the start of every trial day, participants remained within the
time zone of the research center (GMT + 1, daylight-saving GMT + 2) to prevent
jetlag, which might confound the test results. During the trial days, no
strenuous physical exercise (including sports) or sleeping was allowed, and
participants kept a log of their activities and caffeine intake. They were able
to consume their normal amount of caffeine-based products until 5:00 PM. To
avoid interference from caffeine with vigilance, the participants ceased their
consumption of caffeine products from 5:00 PM on the test days.On three consecutive days before each test day, the participants recorded their
fatigue level, sleep hygiene and habits, and daily caffeine intake in a journal.
These results will be analyzed and published separately. Vital signs
(temperature, blood pressure, and pulse) were collected four times during each
test day, two times prior to medication administration, and 2 and 8 h after
administration (see Adverse events were recorded throughout the study and at every visit after
screening. Subjects were asked about any adverse events multiple times during
the trial days.