Table 1

Study schedule

Study periodsScreening phaseIntervention phase
Preliminary screening of eligibilityProspective PMS screeningL1 OAPersonal meeting (t0)L2 OAMidpoint study contactL3 OAPost-treatment study contact & OA (t2)
Visit/contactPhone/post/onlineAt home (diary form)OnlineAt study siteOnlineAt study site or phone/SkypeOnlinePhone
+post-treatment online
Day of menstrual cycle (MC)−31–−1 day of 1. MC1. 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 phaseAt any pointOne whole MCLutealFollicularLutealFollicularLutealFollicular
Time (min)202 daily for 1 MC106010151030
Study information/informed consentx
Inclusion/exclusion criteriaxxx
Randomisationx
Placebo dragée intake in intervention armsxxxx
Narrative for OLP+ groupxx
Primary outcome
PMS symptom diaryxxxxxx
Safety variables xxxxx
Suicidality assessmentxxxx
Side-effects assessmentxx
  • L, luteal phase; OA, online assessment; OLP, open-label placebo; PMS, premenstrual syndrome.