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The telephone calls consisted of a standardized assessment of concomitant medication, compliance assessment, adverse event surveillance and exacerbation history.
At each subsequent clinic visit, all the above evaluations were repeated and review of concomitant medication, compliance assessment, adverse event surveillance and exacerbation history were performed.
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Adverse events, assumption of concomitant medications, and compliance to treatment were assessed at each visit.
Concomitant medications and compliance with the therapy were not reported in this study, which could be considered as a limitation.
Telephone contact was made on day 2, 6, 12, and 14 in order to assess subject diary information, adverse events (AEs), concomitant medications, and compliance with the study medication.
Adverse events, concomitant medication and treatment compliance were recorded at each follow-up visit.
Genetic factors, chronic comorbidity, diet, concomitant medication and patient compliance can have an impact on target INR management [ 38].
Consequently, all of the implicit differences in the two treatments were compared, including factors such as frequency of irradiations, dosage, compliance, concomitant medication, support and equipment.
Age, disease, comorbidities, concomitant medication, organ function and patients' compliance may partly explain the differences.
Further study parameters included time to symptom resolution, treatment compliance and concomitant medication intake.
During each study visit, clinical events, study drug compliance and concomitant medication usage are documented.
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