[Summary text]
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
“Randomization occurred at baseline (day 0) and eligible participants were randomized, using a 1:1:1
ratio, to GXR, ATX or placebo (automatically, randomly assigned by the interactive voice response
system).” (Journal article, pag. 1863)
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Randomization occurred at baseline (day 0) and eligible participants were randomized, using a 1:1:1
ratio, to GXR, ATX or placebo (automatically, randomly assigned by the interactive voice response
system).” (Journal article, pag. 1863)
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Matching placebo tablet” (Journal article, pag. 1863) Information form full CSR, pag. 15 (available upon
request from manufacturer)
Detection bias due to knowledge of the allocated interventions by outcome assessors
Not specified
Attrition bias due to amount, nature or handling of incomplete outcome data
One patient was randomized to GXR but did not receive any treatment and was excluded from the FAS
and the safety population. Quite unbalanced drop outs for lack of efficacy (GXR: n=5/115; ATX: n=5/112;
PBO: n=14/111). (Journal article, fig. 2).
Reporting bias due to selective outcome reporting
No protocol available; Manufcaturer confirmed that all the outcomes of interest for the present metaanalysis
are reported in the Journal article
Bias due to problems not covered elsewhere in the table
None