Sentinel Subject / Group = One active- and one placebo-treated subject at the start of the study and at each dose increment. 

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  • One person in the first cohort of participants is dosed in advance of the full study or in advance of any full cohort. The very first subject who receives the sentinel dose is called ‘sentinel subject’.  
  • This would stagger patient enrollment and is included in FIH trials for safety. 
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