-Existing POC designs in anxiety disorders.
-Preclinical data on BNC210 and model alignment between species.
-Principle of model and historical data for response rate and magnitude of drug response
-Simulations and hypotheses for sample size based on in-house data and literature
-End of planned cohort estimation of response rate and analysis of causative factors for deviation from theory
-Follow up of response rate by clusters of subjects and termination of study
-Post mortem analysis of design :monitoring methods for the ongoing study and improvements (semi-continuous assessment of response rate and early triggering of actions).
-Final analysis of the power obtained at the end (lack of dilution by non- responders)
-Statistical message to take home
-Clinical data on BNC210 tolerability and panic response to CCK.