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Participants switch to the other allocated group immediately after completion of study period 1.
After completion of study period one patient (10%) in Group 1 and two patients (20%) in Group 2 died (P = 0.50).
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Patient follow-up extended from the index date until occurrence of cardiovascular hospitalization or death, termination of database enrollment, or completion of the study period, whichever occurred first.
Missing time was censored at time of withdrawal or completion of the study period including immigrant and emigrant subjects.
On completion of the study period, all prospectively completed forms were centrally collated and data transcribed to a centrally held, electronically secure database.
Clinicians were e-mailed a link to an electronic version of the survey following the completion of the study period.
Three-day dietary records are completed at baseline and at the completion of the study period to assess recent dietary patterns.
Upon completion of the study period, outcome data was extracted by one of the study coordinators (KK).
After completion of the study period the lambs were euthanized by lethal dose of pentobarbital (100 mg/kg intravenously).
All data obtained until the completion of the study period were included in the safety analyses.
Measured prolactin levels will not be made available until the completion of the study period.
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CEO of Professional Science Editing for Scientists @ prosciediting.com