Table 2.

Recommended Additions and Changes to Evaluation of Trial Quality

Randomization	Quality of randomization
Masking	Proper evaluation of success
Allocation Concealment	Proper evaluation of success
Withdrawals and Dropouts	Run-in selection bias Proper ITT and sensitivity analyses
Baseline data	Measured before randomization
Endpoints	Maximally informative, clinical (not surrogate) endpoints, pre-specified
Stopping rules	Account for any interim analysis
Statistical methods	Minimal assumptions, adhere to the scale of measurement, pre-specified
Measures of Variability	Necessary data table presented
Address Multiplicity	Adjust p-values for multiple testing