Table 2.
Risk of bias assessment
| Study | Random sequence generation | Allocation concealment | Blinding | Efficacy analysis | Lost to follow-up | ITT | Statistical analysis |
|---|---|---|---|---|---|---|---|
| Asnis et al11 | Y | Y | Y | MMRM | Y | Y | ANCOVA |
| Bakish et al12 | Y | Y | Y | MMRM | Y | Y | ANCOVA |
| Gommoll et al13 | Y | Y | Y | MMRM | Y | Y | ANCOVA |
| Sambunaris et al14 | Y | U | Y | FAS | Y | N | ANCOVA |
| Montgomery et al15 | Y | Y | Y | MMRM | Y | Y | ANCOVA |
Abbreviations: ITT, intention to treat; Y, yes; MMRM, mixed-model for repeated measures; ANCOVA, analysis of covariance; U, unclear; FAS, full analysis set; N, no.