Table 2 - Information required to document the flow of participants through each stage of a randomised trial Stage Number of Number of Rationale people people not included included or excluded Enrolment People People who These counts evaluated did not indicate for meet the whether trial potential inclusion participants enrolment criteria or were likely to met the be inclusion representative criteria but of all patients declined to seen; they are be enrolled relevant to assessment of external validity only, and they are often not available. Randomisation Participants Crucial randomly for defining assigned trial size and assessing whether a trial has been analysed by intention to treat. Treatment Participants Participants Important allocation who who did counts for received not receive assessment of treatment treatment internal as as validity and allocated, allocated, interpretation by study by study of results; group group reasons for not receiving treatment as allocated should be given. Follow-up Participants Participants Important who who did counts for completed not assessment of treatment complete internal as treatment validity and
Table 2 - Information required to document the flow of participants through each stage of a randomised trial Stage Number of people included Number of people not included or excluded Rationale Enrolment People evaluated for potential enrolment People who did not meet the inclusion criteria or met the inclusion criteria but declined to be enrolled These counts indicate whether trial participants were likely to be representative of all patients seen; they are relevant to assessment of external validity only, and they are often not available. Randomisation Participants randomly assigned Crucial for defining trial size and assessing whether a trial has been analysed by intention to treat. Treatment allocation Participants who received treatment as allocated, by study group Participants who did not receive treatment as allocated, by study group Important counts for assessment of internal validity and interpretation of results; reasons for not receiving treatment as allocated should be given. Follow-up Participants who completed treatment as Participants who did not complete treatment Important counts for assessment of internal validity and
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