• Was the study described as randomized?

• Was the study described as double blind?

• Was there a description of withdrawals and dropouts? (The number and the reasons for withdrawal in each group must be stated. If there were no withdrawals, it should be stated in the article.)

A score of 1 point is given for each "yes," a score of 0 points is given for each "no."

• One additional point is given if for question 1 the method to generate the sequence of randomization was described and it was appropriate (i.e., if it allowed each study participant to have the same chance of receiving each intervention and the investigators could not predict which treatment was next).

• One additional point is given if for question 2 the method of double blinding was described and it was appropriate (i.e., if it is stated that neither the person doing the assessments nor the study participant could identify the intervention being assessed, or in the absence of such a statement the use of active placebos, identical placebos, or dummies is mentioned).

• One point is deducted if for question 1 the method to generate the sequence of randomization was described and it was inappropriate (e.g., patients were allocated alternately).

• One point is deducted if for question 2 the method of doubleblinding was described and it was inappropriate.
