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For too many women, joyfully anticipated pregnancy and motherhood bring depression as an unexpected accompaniment.
Methotrexate had been administered from 1994 to 1999, discontinued due to anticipated pregnancy, and resumed in 2002.
Pregnancy or anticipated pregnancy, use of incretin therapies within 3 months or thiazolidinedione monotherapy were exclusion criteria, as were clinically active cardiovascular, eye, liver, renal, neurological, endocrine or other major diseases.
The reasons for surgical excision of some lesions with benign findings on CNB pathology included imaging/pathology discordance, patient preference, anticipated pregnancy, and significant increase in size on follow-up imaging.
We will therefore aim to recruit a total of 1600 pregnant women to achieve our target number for analysis, as this takes into account anticipated pregnancy loss and loss to follow up.
Exclusion criteria included type 1 diabetes, current or anticipated pregnancy; treatment with OHAs alone (including thiazolidinediones) or exenatide, pramlintide or any other insulin preparation (i.e. premixed or short-acting insulins).
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The sample size needed for this trial was largely determined by the chosen pre-defined non-inferiority margin (i.e. smaller margin requires larger sample size to maintain the same power) but also depended on the anticipated ongoing pregnancy rate (i.e. higher pregnancy rate requires larger sample size) to be expected in a combined trial comprising sites in Europe, USA and Canada.
Given the anticipated high number of pregnancy related hospital attendances and admissions, SAEs will be further assessed to identify those that are clinically complex or serious.
Exclusion criteria included preexisting dementia or schizophrenia, preoperative psychotropic medication use, active or recent substance abuse/dependence, stroke within the last six months, advanced heart block, pregnancy, or anticipated need for deep hypothermic circulatory arrest.
Week 40 of the pregnancy is the anticipated due date but only about 5% of babies are born on exactly the estimated date of delivery.
By contrast, when factors underlying poor contraceptive use prior to the unplanned pregnancy remain unaddressed, the anticipated increased likelihood of contraception use may not be recorded [ 13].
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