Women returned to the clinic for a study visit on Weeks
4–6, then for visits approximately every 12 weeks (Weeks
16, 28 and 40). At all visits, urine pregnancy tests were
performed, vital signs were assessed, concomitant medications
were reviewed and adverse events (AEs) were
recorded. During the trial, all women completed electronic
patient-reported outcomes diaries to record DSG/EE administration,
bleeding/spotting, use of other contraceptives and
DSG/EE compliance. Treatment compliance was also
assessed by tablet counts at scheduled study visits. At all
follow-up visits, women were asked if they remained at risk
for pregnancy; women who said no were discontinued from
the study