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Compliance with study treatments was 80% at 12 months.
Enrolment in the LTFU required participation in the Pathway CH-1 study, continued microstimulator implantation, compliance with study protocol, and written informed consent.
Compliance with study medication was 94% for both treatment groups.
Desire for compliance with study results and a motivation to 'please' and do 'the right thing' must be carefully considered when dealing with the personality trait conscientiousness and its impact on pain perception.
Other exclusion criteria comprised patients with uncontrolled concomitant illness including but not limited to ongoing or active infection, HIV+ on anti-retroviral therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements.
Compliance with study medications was also assessed.
We used two methods to evaluate compliance with study supplements.
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Inappropriate use (non-compliance with study guidelines) of antibiotics was high in two study sites.
No early PD patients and one advanced PD patient discontinued due to non-compliance with study drug.
It is possible that these differences are due to variations in sample timing, handling or processing or non-compliance with study medication.
Withdrawal criteria were voluntary abandonment on the part of the patient and non-compliance with study requirements (not attending one of the scheduled visits in the intervention, refusal to provide blood samples or to complete the questionnaires).
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