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Cycle length is typically 8 to 12 weeks, with physician reassessment before continuing
Insufficient human clinical trials have led to a lack of data to determine a safe dose
Anti-inflammatory signaling Downregulates pro-inflammatory cytokines
SURMOUNT-5 is the only direct head-to-head trial among the three
Dose-escalation decisions in both phases are evaluated by a Safety Review Committee (SRC) , which assesses clinical, pharmacokinetic and safety data according to predefined stopping rules established in the study protocol
Epub 2014 Nov 29
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