Section/topic | Item number and description | Fully reported | Partially reported | Not reported |
---|---|---|---|---|
Title | 1. Identification of the study as randomized | 14 (1.01) | – | 1371 (98.99) |
Authors | 2. Contact details for the corresponding author | 234 (16.90) | 1151 (83.10) | – |
Trial design | 3. Description of the trial design (e.g., parallel, cluster, non-inferiority) | 1301 (93.34) | – | 84 (6.66) |
Participants | 4. Eligibility criteria for participants and the settings where the data were collected | 314 (22.67) | 1071 (77.33) | Â |
Interventions | 5.Interventions intended for each group | 893 (64.48) | 391 (28.23) | 101 (7.29) |
Objective | 6.Specific objective or hypothesis | 1374 (99.21) | – | 11 (0.79) |
Outcome | 7.Clearly defined primary outcome for this report | 0 (0) | 761 (54.95) | 624 (45.05) |
Randomization | 8.How participants were allocated to interventions | 312 (22.53) | 957 (69.10) | 116 (8.38) |
Blinding | 9.Whether or not participants, caregivers, and those assessing the outcomes were blinded to group assignment | 1 (0.07) | 12 (0.87) | 1372 (99.06) |
Numbers randomized | 10.Number of participants randomized to each group | 1097 (79.21) | 12 (0.87) | 276 (19.93) |
Recruiting objects | 11.Clinical Trial Status | 0 (0) | 714 (51.55) | 671 (48.45) |
Numbers analyzed | 12.Number of participants analyzed in each group | 44 (3.18) | 6 (0.43) | 1335 (96.39) |
Outcome | 13.For the primary outcome, a result for each group and the estimated effect size and its precision | 0 (0) | 63 (4.55) | 1322 (95.45) |
Harms | 14.Important adverse events or side effects | 150 (10.83) | 188 (13.57) | 1047 (75.60) |
Results | 15.Generalized interpretation of outcome | 1375 (99.28) | – | 10 (0.72) |
Trial registration | 16.Registration number and name of trial register | 0 (0) | 1 (0.07) | 1384 (99.93) |
Funding | 17.Source of funding | 2 (0.14) | 284 (20.51) | 1100 (79.42) |