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Reacher 1990 randomly allocated procedures using random number tables.
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Of 858 patients randomized to CEA, the allocated procedure was initiated in 821 (95.7%).
However, the data-analyst will be blinded for the allocated procedure (Fig. 1).
The allocated procedure will be performed as an inpatient within 3 days of randomisation taking place.
12 The designated member then booked the allocated procedure and notified the patient.
The data were analysed per-protocol; only patients in whom the randomly allocated procedure was initiated were included in this analysis.
All 30 communities adhered to allocated study procedures, including follow-up examinations (Fig. 1).
Although the allocated trial procedure may be performed within 3 days of randomisation, every effort should be made to perform the procedure immediately afterwards.
The subjects will be informed about the allocated operative procedure shortly after the randomization.
The trial was non-blinded as it was impossible to blind surgeons and women to the allocated surgical procedure.
The allocated drainage procedure should be repeated until internal biliary drainage of the FLR has been achieved (i.e. technical success).
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