1. Study described as ramdomised (this includes the use of words such as “random”, “randomly” and “randomisation”) |
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2. Study described as double blind? |
3. Description of withdrawals and dropouts? |
4. Method to generate the sequence of randomisation described and appropriate (table of random numbers, computer generated, etc)? |
5. Method of double blinding described and appropriate (identical placebo, active placebo, dummy etc)? |
6. Method to generate the sequence of randomisation described and inappropriate (patients were allocated alternately or according to their date of birth, hospital number, etc). |
7. Method of double blinding described and inappropriate (e.g. comparison of tablet vs. injection with no double dummy). |
For questions 1–5 Yes = 1 point and No = 0 points. Deduct 1 point if questions 6 or 7 apply.