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The ADHD-RS-IV was administered at baseline and each visit thereafter to assess efficacy.
Subjects were queried at Day 0 and each visit thereafter regarding adverse experiences, concomitant medications, and adherence to study medication.
To mitigate such artifacts and allow detection of regrowth after initial ablation, the first formal response assessment occurred at week 8 and was repeated at each visit thereafter.
At the six week follow-up visit and each visit thereafter patients will be asked to complete the Quick-DASH, Oxford Elbow Score, and SF-36 questionnaires.
Treatment with duloxetine versus placebo significantly improved fatigue across all of the MFI domains within 4 weeks and continued to improve at each visit thereafter, and improvement was maintained for up to 24 weeks.
At each visit thereafter, the clinician used the CGI-I to rate improvement relative to baseline on a scale ranging from 1 (very much improved) to 7 (very much worse) plus a not assessed option.
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Significant improvement in HAMA total score and HAMA psychic anxiety subscale score for the escitalopram-treated group vs. the placebo-treated group was observed beginning at Week 1 and at each study visit thereafter.
Face-to-face adherence reminder sessions will take place at the initial product dispensing and each study visit thereafter.
Blood, dialysate effluent, fingernail and hair samples are obtained at baseline, 6 months, 12 months and at each study visit thereafter, according to standard protocols.
For the first 4 visits and for each annual visit thereafter, subjects answered a nurse-administered questionnaire designed to collect information on socio-demographic, lifestyle, sexual, reproductive and contraceptive characteristics.
A face-to-face adherence discussion will take place at the initial visit and at each study visit thereafter, emphasising the importance of following study guidelines and the instructions about taking the study product.
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