Describe procedures to be used for dealing with premature discontinuation from the study or treatment and the handling of spurious or missing data (e.g. use of multiple imputation, random effects models or complete case analyses). Describe any possible biases these techniques may introduce. Describe the underlying assumptions (e.g. Missing At Random) in both statistical and non-statistical terms. Describe procedures to be used for describing the pattern of permanent (i.e. dropout) or transient missing data.
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