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The caveats of a study will apply to this phase in terms of **confounding factors**: such as any imbalances in the risk factors that may influence and/or have impact on the clinical outcome of interest; biases: such as any differential data collection and/or different clinical practices in clinical outcome collection and evaluation; time-varying covariates: patients taking on various therapies for their diseases that may further erode any treatment effect that may result from the treatment phase of the study.