| Methods | For characteristics see Fundamental 2014a1 | |
| Participants | ||
| Interventions | ||
| Outcomes | ||
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | There was only missing data for 2 participants |
| Selective reporting (reporting bias) | High risk | The secondary outcomes were changed from the original secondary outcomes |
| Vested‐interest bias | High risk | The study was funded by Novartis |
| Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias |
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