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Before the study commenced 10 randomly selected tablets of study drug were analyzed in-house for content and weight uniformity according to standard guidelines [11][12]: the mean AS content was 45.9 mg (range 41.3 50.2 mg), and dihydroartemisinin (DHA) impurity was 1.31% (range 1.03 1.62%).
Two tablets of study drug (Diclegis® or placebo) were administered at bedtime on Day 1.
Two boxes (one box for the first menstrual migraine attack of one menstrual cycle and the other for the first menstrual migraine attack occurring in the subsequent menstrual cycle) per patient were provided, each containing two tablets of study medication or placebo in sealed blisters.
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The number of tablets of the study drug taken was calculated from the drug dispensation log.
Eligible patients received 2 tablets of the study drugs (exemestane 25 mg plus anastrozole placebo or anastrozole 1 mg plus exemestane placebo) and were instructed to take the tablets orally once daily with food.
Safety analyses were performed on all randomized participants who took one or more tablets of the study drug and had at least one contact or assessment with the investigative site at any time after beginning the study.
Participants were asked to take two tablets of the study medication before operation (as close as possible to the start of surgery) and then 4 times a day (as close as possible to 6 hourly) for up to 48 h after surgery.
A 95% confidence interval will be reported to check if the expected rate of 80% dosage of study tablets for the duration of the study protocol by all patients is obtained.
To assess compliance, the total number of study tablets reported as having been taken was expressed as a percentage of the number of days between the study consent date and the date of giving birth.
The predetermined primary outcome was withdrawal ("drop-out") after visit 2 due to perceived lack of efficacy of study tablets (prednisone or placebo), ie, during the "transfer" or "comparison" phases of the trial, versus remaining in the trial until completion of the 24-week "comparison" period.
(IDI, female, tablet, very low uptake) The majority of study participants (9 smartablet/10 tablet) were quoted saying that both devices give correct classifications.
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CEO of Professional Science Editing for Scientists @ prosciediting.com