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Follow-up calls/visits are scheduled for the period from 1 month prior to the enrollment anniversary (i.e., date of consent and baseline visit), to preferably 1 month, but not more than 3 months, after the enrollment anniversary.
Most women (85%) completed the intervention on the date of consent.
Ninety-one (81.3%) of the 112 subjects were diagnosed with diabetes more than 2 years prior to the date of consent, and another 15 (13.4%) were diagnosed with diabetes one year prior to the date of consent (Table 1).
Adverse events and concomitant medications were recorded on an ongoing basis from the date of consent until the final visit.
Overall survival was measured from the date of consent to the use of vinflunine to the date of death from any cause.
Supporting data were gathered through departmental tracking databases (including landmark dates such as date of consent, date of initial visit, date of surgery, etc).
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All concomitant medications and therapies that were ongoing at the date of informed consent were recorded.
The proposed inclusion criteria are as follows: 1) Age 40 to 80 years as on the date of informed consent.
Participation in the study and date of informed consent patient are being documented appropriately in each patient's files.
The duration of PHN was defined as the number of months between the PHN start date and the date of informed consent.
20 For this study, we excluded women with no information on the date of the consent agreement (n=34), women who entered the cohort after 22 weeks of pregnancy (n=1661), women with no information of the date of the pregnancy outcome (n=81) and women with ectopic pregnancies (n=66) or mola hydatidosa (n=48).
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CEO of Professional Science Editing for Scientists @ prosciediting.com