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These side effects were designated as mild (no interference with daily activities), moderate (some interference with daily activities), or severe (significant, prevented daily activity).
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Mild (does not inhibit daily activities)/moderate (inhibiting, but not preventing daily activities)/severe (daily activities suspended) 20.
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All adverse events were graded for severity: mild (easily tolerated), moderate (interferes with daily activity or required remedial therapy), or severe (prevents daily activity).
Pain and solicited adverse events other than fever and urticaria were graded as follows: 0 = absent/none, 1 = easily tolerated, 2 = interferes with daily activity, 3 = prevents daily activity.
The incidences of solicited symptoms, as well as of those graded 3 (i.e. preventing daily activity, or swelling >30mm, or rectal fever >40°C), within the 4-day follow-up period were tabulated over the whole primary vaccination course (i.e. per dose), with exact 95% CIs.
Flu was particularly perceived as preventing daily activities, including being unable to work or to take care of relatives.
In addition, since the weekly duration of exercise significantly increased following CSII, the CSII equipment is unlikely to prevent daily exercise.
No events were classified as preventing daily activities and the incidences of local redness and swelling reactions above 50 mm diameter were low (1.7% and 2.3% respectively).
The majority of reactions in TIV recipients were mild to moderate in intensity, there were no reports of fever >39°C and the highest incidence of symptoms preventing daily activities and reported as related to vaccination was 0.5% (fatigue and headache).
We defined successful use of CGM as an average of ≥6 days/week to allow for the possibility of issues such as device inoperability, exhausted sensor supply, or other problems that might prevent daily use for a few days.
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