|
Sequence
g
eneration
| Low: table of random digits | Low | Low: randomised stratified per centre and sex. Computer-generated randomisation list |
|
Allocation
c
oncealment
| Unclear: no information provided | No comment | Low: treatment allocation completed after urine culture results. Restricted access to independent pharmacy |
|
Blinding of participants and personnel for all outcomes
| Unclear: no description of the blinding provided | High: no blinding of the participants or personnel only investigators | Low: double blinding |
|
Blinding of outcome assessors for all outcomes
| Unclear: no description of the blinding provided | Low: investigators were blinded through third party. The drugs were dispensed by an independent third party to ensure investigator blinding | Low: analysis based on intention to treat population |
|
Incomplete outcome data for all outcomes
| High: data not reported for two patients in each group suffering adverse events | High: the main outcome (clinical recovery) is reported for 436/727 patients only | Low |
|
Selective outcome reporting
| Low | Unclear: both outcomes assessed were reported, but no pre-published protocol is available to control this with the initial design | Unclear: all outcomes described in methods chapter are reported |
|
Other sources of bias
| Low | High: men are just 5% of population and a subgroup of the study. Dropout is about 50% for bacteriological cure and unclear for clinical cure. | None identified |