1 Clear definition of the objective of the study |
2 Study design adequate for the objective of the study |
3 Clear definition of the primary endpoint |
4 Clear definition of the secondary endpoints |
5 Adequate blinding of the study (at least double-blind) |
6 Adequate randomisation and adequate description of the randomisation |
7 Adequate presentation of early terminations/withdrawals from the study |
8 Placebo-control group |
9 A priori sample size calculation |
10 Patient population representative of self-medication (patients e.g. with mild to moderately severe migraine and/or tension-type headache; no in-patients) |
11 Adequate statistical methods and analysis |
12 Correct interpretation of the statistical results |