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It should be noted, however, that the use of additional medication in our sample was quite low.
In conclusion, we demonstrated that acute exacerbations require the use of additional medication, even in an outpatient clinic, that could be detected statistically over a 6-month period.
Recruitment through community-based gastroenterologists might have been one contributing factor, but lack of efficacy, especially in the placebo group, could have also encouraged the use of additional medication not allowed by the protocol.
For doxycycline, side effects caused a doctor visit in 59.5%, the use of additional medication in 52.8%, discontinuation in 42.7%, a dose change in 16.7%, missed work 6.8%, and hospitalizations in 1.3%.
The use of additional medication or healthcare resources (such as hospital admissions and outpatient clinic visits) will be measured based on the patients' self-reports via telephone interviews 72±12 h after ED discharge via a phone call.
It assesses the frequency of gastroesophageal reflux symptoms over the past 2 weeks and their impact on everyday activities such as sleep, work, meals and social occasions, and the use of additional medication (other than that prescribed).
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The use of additional medications (e.g., anti-nausea drugs, antidepressants, over-the-counter flu medications) was reported as helpful, as were exercise, rest, positive thinking, and distraction.
Patient demographics, clinical features and follow-up information such as treatment response and patient use of additional medications were studied to calculate the expected incidence rates of serious infections for defined subgroups of patients.
It is also worth noting that in this series no attempts were made to regulate the prescription or use of additional medications such as local or systemic steroids and antihistamines, thus limiting the effectiveness of this comparison.
Criterion B involves B1: the number of episodes off the treatment, B2: frequency of episode off the treatment, B3: the duration of treatment, B4: compliance during period(s) of stability, and B5: the use of additional medications during the periods of stability.
The use of additional rescue medication to relieve pain during the ED stay and the length of stay in the ED (from group allocation to ED discharge) will be measured based on electronic medical charts.
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