Observed flow of patients in the trial. * Returned all capsules (lack of adherence), unknown reason. ** Returned all capsules (unknown reason) (3), family opposed participation in the trial (1), pregnant woman suffered abortion (1), participant presented with UTI (1); the last two events occurred on the day that they were randomly assigned. *** Randomisation error (3): Nugent score < 4 (2); gestational age miscalculation (1). **** Randomisation error (1): Nugent score < 4.