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. 2020 Feb 17;10(2):e032868. doi: 10.1136/bmjopen-2019-032868

Table 1.

Study schedule

Study periods Screening phase Intervention phase
Preliminary screening of eligibility Prospective PMS screening L1 OA Personal meeting (t0) L2 OA Midpoint study contact L3 OA Post-treatment study contact & OA (t2)
Visit/contact Phone/post/online At home (diary form) Online At study site Online At study site or phone/Skype Online Phone
+post-treatment online
Day of menstrual cycle (MC) −31–−1 day of 1. MC 1. day of 1. MC until end of 1. MC −5–−1 of 2.
MC
1–14 day of 2. MC −5–−1 of 3.
MC
1–14 day of 3. MC −5–−1 of 4.
MC
1–14 day of 4. MC
Menstrual phase At any point One whole MC Luteal Follicular Luteal Follicular Luteal Follicular
Time (min) 20 2 daily for 1 MC 10 60 10 15 10 30
Study information/informed consent x
Inclusion/exclusion criteria x x x
Randomisation x
Placebo dragée intake in intervention arms x x x x
Narrative for OLP+ group x x
Primary outcome
PMS symptom diary x x x x x x
Safety variables x x x x x
Suicidality assessment x x x x
Side-effects assessment x x

L, luteal phase; OA, online assessment; OLP, open-label placebo; PMS, premenstrual syndrome.