In this part of the trial, data were collected in two ways.
However, the trial data were collected during the patients' ED stay only, and did not continue to follow them after admission to a hospital ward.
No further trial data is collected from control arm participants thereafter.
Trial data are collected from participants during three clinic visits (at baseline, 4 and 12 months) and by postal questionnaire at 6 months.
Trial data was collected from the original publication including the authors' names, the journal, year of publication, country of origin, number of participating centers, inclusion and exclusion criteria, stratification, major and minor endpoints, number of arms, sample size per arm, regimens used, doses and line of treatment using a piloted data extraction form.
For calculation of baseline sigma level after few trials the data were collected for 25 samples having subgroup size 36.
Across the 14-week trial period, data were collected at baseline and subsequent fortnights.
They also used their habitual refractive correction and kept their eyes open throughout the trial meaning that data were collected in closed-loop conditions.
Objective response by RECIST criteria was not a defined end point of any of the trials from which these data were collected; however, unconfirmed responses were recorded as part of the record-keeping for trials 1 and 3.
34 We will exclude protocols of trials, observational studies, secondary reports of trials, studies in which no data were collected at the individual level and quasi-experimental cluster designs.
