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Tab isoptin doses of the experimental agent and its use as a comparator; and (6) the total daily doses and timing of the exposure to drug and its use as a comparator. final decision on the efficacy of drug was based on a combination of (2) exposure duration, (3) dose schedule, (4) pharmacokinetics, (5) toxicology and human animal safety, (6) the available evidence of pharmacodynamic and pharmacokinetic effects in healthy humans. METHODS: This observational cohort study consisted of participants aged 20-55 years who were enrolled in the trial 2006. A total of 866 participants were randomized and enrolled across two consecutive 5-week treatment periods. At each and follow-up visit, participants completed several questions on drug use. RESULTS: Of 866 participants enrolled, 865 (96%) participated in treatment for ≥ 2-months (median length of treatment = 4.0+ months). The median number of daily doses study drugs reported to the trial registration was 2.8 (interquartile range=1.5-10.0) and average dose per participant was 0.6 (range=0.0-3.2). Participants generally exceeded their treatment dosing, including: 4 of 9 (89%) participants had higher daily doses than prescribed; 6 of 9 (89%) exceeded their maximum dose limit; 9 of 12 (92%) exceeded the recommended safety margins; 9.5% had an overdose of any the 4 drugs that they were randomized; and, of 30 the 33 cases adverse effects, majority occurred during or after therapy, including 11 that required hospitalization. CONCLUSIONS: The incidence of drug overdose or other adverse events associated with exposure to at least one of the doses experimental agents in this trial was significantly greater than those found in our experience with similar therapeutic agents. The clinical relevance of these findings, particularly with regard to doses recommended for treatment, has not been established. However, the clinical experience with other doses is consistent the findings from this study. SUPPLEMENTARY MATERIAL: Supplementary data available from the trial registration.

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