CONSORT_protocol.Rmd

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output:
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Funding:

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```{r setup, include=FALSE}
knitr::opts_chunk$set(echo = TRUE)

library(projects)
library(here)
library(tidyverse)
```

# Abstract
1a  Identification as a randomised trial in the title
1b	Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)

# Introduction

## Background/rationale
Scientific background and explanation of rationale

## Objectives
Specific objectives or hypotheses

# Methods

## Trial design
Description of trial design (such as parallel, factorial) including allocation ratio
Important changes to methods after trial commencement (such as eligibility criteria), with reasons

## Participants
Eligibility criteria for participants
Settings and locations where the data were collected

## Interventions
The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

## Outcomes
Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed
Any changes to trial outcomes after the trial commenced, with reasons

## Sample size
How sample size was determined
When applicable, explanation of any interim analyses and stopping guidelines

## Randomisation:

### Sequence generation
Method used to generate the random allocation sequence
Type of randomisation; details of any restriction (such as blocking and block size)

### Allocation concealment mechanism
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

### Implementation
Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions

## Blinding
If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how
If relevant, description of the similarity of interventions

## Statistical methods
Statistical methods used to compare groups for primary and secondary outcomes
Methods for additional analyses, such as subgroup analyses and adjusted analyses

# Results

## Participant flow (a diagram is strongly recommended)
For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome
For each group, losses and exclusions after randomisation, together with reasons

## Recruitment
Dates defining the periods of recruitment and follow-up
Why the trial ended or was stopped

## Baseline data
A table showing baseline demographic and clinical characteristics for each group

## Numbers analysed
For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups

## Outcomes and estimation
For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)
For binary outcomes, presentation of both absolute and relative effect sizes is recommended

## Ancillary analyses
Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory

## Harms
All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)

# Discussion
## Limitations
Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses

## Generalisability
Generalisability (external validity, applicability) of the trial findings

## Interpretation
Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence

# Other information

## Registration
Registration number and name of trial registry

## Protocol
Where the full trial protocol can be accessed, if available

## Funding
Sources of funding and other support (such as supply of drugs), role of funders

\pagebreak

## References

```{r session_info, include=FALSE}
save_session_info(here("progs", "session_info", "protocol"))
```