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The number of embryos in the brood pouch and adult mortality serve as main endpoints.
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Nevertheless, this bias was probably reduced, as our main endpoints were clearly defined.
Differences in mean values and standard deviations were extracted as the main endpoints.
The following neonatal outcomes were chosen as the main endpoints of the study: neonatal death, neonatal hypotonia, Apgar score <7 at 1 and 5 minutes, intubation at place of delivery, admission to the NICU, treatment in NICU >7 days.
Since several co-regulators of nuclear receptors also modulate response to therapy [ 8, 9], we also assessed, as a secondary aim of this study, the predictive value of DC-SCRIPT by using clinical benefit and progression-free survival (PFS) after first-line tamoxifen for advanced disease as the main endpoints.
As far as the main endpoint was considered (percent time with intragastric pH > 3), there was no statistically significant difference between both drugs.
Consequently, nowadays these outcomes are often considered as main secondary endpoints or even primary endpoints in clinical studies [ 1- 4].
The use of inpatient death as the main endpoint (vs. mortality within a fixed time, such as 30 days or one-year from admission, data not available in our study) involves several inconveniences [ 48].
2 Although we did not study specific complications, we focused on reintervention as a main endpoint of our analyses.
We chose the body mass index (BMI) as the main endpoint because its components can be easily measured and it can be easily compared with published data.
These publications focused on revision surgery as the main endpoint and did not present any specific information about patients without symptoms of implant failure.
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