| OUTCOMES | |||||||
| Follow‐up periods | List all follow‐up periods given in report | ||||||
| Total no. of randomized participants | Participants in experimental group | Participants in control group | |||||
| Primary outcomes | |||||||
| (dichotomous 'end point' outcome) | Participants analysed | Number of events in the groups: E = experimental C = control |
Bias of the outcome | ||||
| All‐cause mortality | Maximum follow‐up | E (n) | E (n) | L / U / H | |||
| C (n) | C (n) | ||||||
| End of trial intervention period | E (n) | E (n) | L / U / H | ||||
| C (n) | C (n) | ||||||
|
Serious adverse events: Nb. Number of counts. If SAE is reported, list them individually |
Maximum follow‐up | E (n) | E (n) | L / U / H | |||
| C (n) | C (n) | ||||||
| End of trial intervention period | E (n) | E (n) | L / U / H | ||||
| C (n) | C (n) | ||||||
| (continuous outcome) | Participants analysed | Mean (endpoint or change) |
SD | Bias of the outcome | |||
|
Quality of life: Type of QoL scale: |
Maximum follow‐up | E (n) | E | E | L / U / H | ||
| C (n) | C | C | L / U / H | ||||
| End of trial intervention period | E (n) | E | E | L / U / H | |||
| C (n) | C | C | L / U / H | ||||