Table 1 Overview of number of visits and outcome assessments

Weeks

+/- 3 or more days

(-4)-(-1)

(+/-3 days)

-1

(+/-3 days)

0

(+/-3 days)

24–26

(+/-3 days)

26

(+/-3 days)

52

(+/-3 days)

Patient history

Extensive patient medical history

x

Changes in medical history

x

x

x

PCOS history and symptoms

x

x

x

Randomisation

x

Endoscopic procedure

x

x

Examinations

Body weight/height

x

x

x

Waist/Hip circumference

x

x

x

Blood pressure, heart rate

x

x

x

Ferriman-Gallwey Score

x

x

x

Questionnaires

Diet (General, vitamin D and calcium)

x

x

x

PCOS

x

x

x

Depression scales

x

x

x

Bristol Stool Scale

x

x

x

Laboratory

Hormone panel

x

x

x

Oral glucose tolerance test

x

x

x

Safety lab (not an endpoint)

x

x

x

Coagulation safety lab

x

FACS

x

x

x

P800 and PAX gene tube

x

x

x

Inflammation, gut permeability

x

x

x

Urine tests

x

x

x

Pregnancy tests

x

x

x

Biobank samples

x

x

x

Isoflavone intake test

Between first and screening visit

Before the second visit

Functional gut permeability test

Between first and screening visit, after isoflavone intake test

Before the second visit, after isoflavone intake test