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Soft tissue sarcomas were included if they were diagnosed before the study end point of 31 December 1990, after which the completeness of ascertainment is uncertain.
Loss to follow-up from the clinic's ART program was defined as having missed ≥3 consecutive monthly refills before the study end date.
After removing the pregnancies conceived more than 19 weeks before the study start and less than 43 weeks before the study end, the adjusted cohort had 101,870 pregnancies (88.6% of the original sample).
The analyses were based on 106,640 individuals for whom an index BMI measurement taken within 1 year after diagnosis of diabetes, and on or before the study end point, was available.
Median follow-up [inter-quartile range (IQR)] was 4.0 years (3.7 4.4) and only 3% were lost to follow-up/withdrew consent (i.e. were last seen before the study end and were not known to have died) [ 2].
A subject exited the study if he or she died from lung cancer (event), died from a cause other than lung cancer before the study end (censored before 31 December 1996), or lived until the end of the study (censored by the end of study).
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Seven patients died before reaching the study end point, leaving 56 patients (89% survival) for analysis of the main outcome variable (Figure 1; Table 2).
Dendreon had always planned to have the independent data safety monitoring board (DSMB) for the trial take a look at the data before the study ended.
Patients were considered to have an interruption in care if they: (i) did not attend scheduled clinic visits for ≥3 months; (ii) did not return to care before the study ended on February 1, 2008; (iii) were not known to be in care at any other hospital or clinic during the study period; and (iv) were not known to have died [12], [14].
No data were analysed before the study ended.
In two of the six provinces infant immunization programs began 3 and 16 months, respectively, before the study ended.
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