Item | Description | Reported on line number |
---|---|---|
Title | Identification of the study as randomized | Â |
Authorsa | Contact details for the corresponding author | Â |
Trial design | Description of the trial design (e.g., parallel, cluster, non-inferiority) | Â |
Methods | ||
Participants | Eligibility criteria for participants and the settings where the data were collected | Â |
Interventions | Interventions intended for each group | Â |
Objective | Specific objective or hypothesis | Â |
Outcome | Clearly defined primary outcome for this report | Â |
Randomization | How participants were allocated to interventions | Â |
Blinding (masking) | Whether or not participants, caregivers, and those assessing the outcomes were blinded to group assignment | Â |
Results | ||
Numbers randomized | Number of participants randomized to each group | Â |
Recruitment | Trial status | Â |
Numbers analyzed | Number of participants analyzed in each group | Â |
Outcome | For the primary outcome, a result for each group and the estimated effect size and its precision | Â |
Harms | Important adverse events or side effects | Â |
Conclusions | General interpretation of the results | Â |
Trial registration | Registration number and name of trial register | Â |
Funding | Source of funding | Â |