Inclusion criteria | Listed | Listed |
Exclusion criteria | Listed | Listed |
Randomization technique | Computer-based | Computer-based |
Sample size calculation | Not stated | Not stated |
Baseline comparable | Listed | Listed |
Masked/blinded | Not stated | Stated |
Cross-over | Stated | Not stated |
Lost to follow-up | None | None |
Allocation concealment | Not stated | Stated |
Analysis by intention to treat | Not stated | Not stated |