Upon completion of the study visit, participants were asked to complete an ABPM over the next 24 h.
All research associates were issued with several standard operating procedures as to good clinical practice, recruitment, realisation of study visits, completion of questionnaires and of study documents, etc.
A continuous consent process was developed for the main trial in Mwanza, based on experience gained during the feasibility and pilot study phases of the program, and designed to facilitate accurate and comprehensive message retention from the point of first contact in the community to completion of the final study visit at 52 weeks.
Use of concomitant neuropathic pain medication was permitted and documented through completion of the last study visit (week 8 for patients who continued G-GR therapy or week 9 for patients who underwent dose tapering).
During the visits, the monitor carried out a quality control of trial progress in respect to protocol and operating guidelines, data collection, completion of consent forms, completion of study documents, SAE reporting, and samples and IMP management.
We analysis all of the outcomes assessed at TOC visit which varied between the RCTs, with a minimum value of 10 days, to a maximum value of 4 weeks, after the completion of study treatments.
To determine the acceptability of the mTCNS to patients, a cognitive debriefing substudy was conducted in 12 randomly selected patients (three from each study site) after the completion of their two study visits.
Instructions were that study drugs should be taken daily upon wakening at approximately 0700 hours, beginning on the day after completion of the baseline visit (visit 0).
Dosing began (at approximately 0700 hours) on the day after completion of the baseline visit (visit 0).
At 3 7 days after completion of all three sessions, a final study visit was conducted which consisted of a physical examination, assessment of laboratory and urinary parameters and final safety evaluation.
