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Table 1 CONSORT 2010 checklist of information to include when reporting a randomized trial

From: Single high-dose buprenorphine for opioid craving during withdrawal

Section/topic Item no. Checklist item Reported on page no.
Title and abstract
  1a Identification as a randomized trial in the title 1
1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) 1
Introduction
Background and objectives 1a Scientific background and explanation of rationale 2
2b Specific objectives or hypotheses 2
Methods
Trial design 2a Description of trial design (such as parallel, factorial) including allocation ratio 2
2b Important changes to methods after trial commencement (such as eligibility criteria), with reasons 2
Participants 2a Eligibility criteria for participants 2
2b Settings and locations where the data were collected 2
Interventions 2 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 2
Outcomes 2a Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 2
2b Any changes to trial outcomes after the trial commenced, with reasons 2
Sample size 2a How sample size was determined 2
2b When applicable, explanation of any interim analyses and stopping guidelines NA
Randomization:    
Sequence generation 2a Method used to generate the random allocation sequence 2
2b Type of randomization; details of any restriction (such as blocking and block size) 2
Allocation concealment mechanism 2 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 2
Implementation 2 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 2
Blinding 2a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 2
2b If relevant, description of the similarity of interventions NA
Statistical methods 2a Statistical methods used to compare groups for primary and secondary outcomes 2
2b Methods for additional analyses, such as subgroup analyses and adjusted analyses 2
Results
Participant flow (a diagram is strongly recommended) 3a For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome 2
3b For each group, losses and exclusions afterrandomization, together with reasons 3
Recruitment 3a Dates defining the periods of recruitment and follow-up 3
3b Why the trial ended or was stopped 3
Baseline data 3 A table showing baseline demographic and clinical characteristics for each group 3
Numbers analyzed 3 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 3
Outcomes and estimation 3a For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) 3
3b For binary outcomes, presentation of both absolute and relative effect sizes is recommended 3
Ancillary analyses 3 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory 3
Harms 3 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) 3
Discussion
Limitations 6 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses 3
Generalizability 6 Generalizability (external validity, applicability) of the trial findings 6
Interpretation 6 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 6
Other information  
Registration 6 Registration number and name of trial registry 6
Protocol 6 Where the full trial protocol can be accessed, if available 6
Funding 6 Sources of funding and other support (such as supply of drugs), role of funders 6