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Patients selected for study inclusion were first identified using the following claims-based eligibility criteria: female patients, fill of at least one month's supply of HT anytime between January 1 , 2007and December 31, 2010 (with the first date of HT deemed the "index date" for analysis), and aged 45 to 65 years of age as of the index date.
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The date for the first low LDL-C measurement in a series of consecutively low LDL-C measurements was considered the index date for the analysis of persistence.
Thus, the index date for the persistence analysis may differ from the analysis based on first-time low LDL-C, because some individuals had changing LDL-C levels and did not achieve a persistently low LDL-C level until later in the study period.
To ensure completeness of exposure data we also excluded temporary residents and patients with fewer than 6 years of medical records before the index date for the main analysis - and fewer than 10 years for the further analysis.
The median follow-up time from study start date to index date for women in the primary analysis was 808 days (interquartile range 456-1131 days) for controls, 654 (313-1038) days for other cases, and 766 (381-1087) days for high grade cases.
We therefore selected the earlier of the two dates as the index date for the 28 day case fatality analysis.
For loss analysis, the index date for women who did not return the questionnaire was the date the questionnaire was sent.
For both cases and controls, only pregnancies before the date of the diagnosis of the case (the index date for the control) were included in the analysis.
For the secondary analysis, we randomly selected an index date for controls from all negative test results to minimise any opportunity for exposure bias.
The date when the study cases were diagnosed with CM was assigned as the index date for both groups.
The index date for the cases was the admission date.
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