1. Title | Identification of the study as randomised | 52 (29.5) |
2. Authors | Contact details for the corresponding author | 0 (0) |
3. Trial design | Description of the trial design (eg, parallel, crossover) | 57 (32.4) |
4. Participant | Eligibility criteria for participants and the settings where the data were collected | 16 (9.1) |
| 4a. Eligibility criteria for participants | 170 (96.6) |
| 4b. Settings of data collection | 16 (9.1) |
5. Interventions | Interventions intended for each group | 130 (73.9) |
6. Objective | Specific objective or hypothesis | 170 (96.6) |
7. Outcome* | Clearly defined primary outcome for this report | 28 (15.9) |
8. Randomisation | How participants were allocated to interventions | 0 (0) |
| 8a. Random assignment | 176 (100) |
| 8b. Sequence generation | 0 (0) |
| 8 c. Allocation concealment | 0 (0) |
9. Blinding (masking) | Whether or not participants, caregivers and those assessing the outcomes were blinded | 14 (8.0) |
| 9a. Generic description only (eg, single blind, double blind) | 45 (25.6) |
10. Numbers randomised | No of participants randomised to each group | 79 (44.9) |
11. Recruitment | Trial status (eg, ongoing, closed to recruitment, closed to follow-up) | 41 (23.3) |
12. Numbers analysed | No of participants analysed in each group | 24 (13.6) |
| 12a. Intention-to-treat analysis or per-protocol analysis | 12 (6.8) |
13. Outcome† | For the primary outcome, a result for each group and the estimated effect size and its precision | 0 (0) |
| 13a. Primary outcome result for each group | 11 (6.3) |
| 13b. Estimated effect size | 5 (2.8) |
| 13 c. Precision of the estimate (eg, 95% CI) | 3 (1.7) |
14. Harms | Important adverse events or side effects | 22 (12.5) |
15. Conclusions | General interpretation of the results | 172 (97.7) |
| 15a. Benefits and harms balanced | 10 (5.7) |
16. Trial registration | Registration no and name of trial register | 6 (3.4) |
17. Funding | Source of funding | 162 (92.0) |