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The sample size calculation using modeling & simulation approach is considered to be more efficient than conventional modeling. The proposal is to compare the power of defining the exposure-response, and thereby establishing efficacy, using model-based approaches. Specifically, a base exposure-IGA score (ordinal scale) relationship will be assumed. Data will be simulated and subjected to conventional and model-based analyses. The model-based approach can test single-point (end of the study) and longitudinal models. The power of the two approaches will be compared. The process will be repeated for different โwhat-ifโ scenarios from the base model. Several details of the simulations are provided by MTPC during the exploratory meeting.
