Signalling questions | Description | Response options |
---|---|---|
5.1 Was the trial analysed in accordance with a pre‐specified plan that was finalized before unblinded outcome data were available for analysis? |
Trial registration: ClinicalTrials.gov identification number NCT00426010 There were no changes to study outcomes after study commencement |
Y |
Is the numerical result being assessed likely to have been selected, on the basis of the results, from… | ||
5.2. … Multiple outcome measurements (e.g. scales, definitions, time points) within the outcome domain? | Measure of fatigue, energy, nausea, systolic blood pressure and conclusion according to results of energy and fatigue only, while no tests found significant difference | Y |
5.3 … Multiple analyses of the data? | PN | |
Risk‐of‐bias judgement | High |
Note: PN, Probably No; Y, Yes.