Figure 1 shows the enrollment and follow-up of the women who participated in the trial.
A total of 10,154 women were randomly assigned to a study group; 5088 were assigned to receive vitamins,and 5066 to receive placebo.
Data for two women were removed, one at the patient’s request and one at the request of the institutional review board at her site (after a lapse in approval by the institutional review board at that site), resulting