Validity

1. Allocation
   1. Randomization
   2. Groups comparison
2. Blinding
   1. Patient
   2. Clinician
   3. Randomization
   4. Adjudicators/Assessors
3. Follow-up
   1. reasons
   2. magnitude
   3. worst-case scenario sensitivity analysis
4. Analysis
   1. ITT vs
   2. subgroups - only pay attention if the overall study is significant
      1. pre-specified/a priori
      2. not too many - due to multiple comparisons effect
      3. likely NOT powered