In the primary analysis we defined statin use based on one or more claims for a dispensed statin from the last menstrual period through day 90 of pregnancy (first trimester), the causal relevant window of exposure for congenital malformations.
For our primary analysis, we defined x i as a categorical variable with four levels: exposed in trimester 1; exposed in trimester 2; exposed in trimester 3; or unexposed.
For the primary analysis, I define a separation to employment as a worker quit from a job spell that results in a new job spell within the next month.
However, in RCTs it is the primary analysis, as defined ex ante, which is most important, and the CGI scores did not represent the primary endpoint in any of the studies selected for synthesis.
For the primary analysis in this study, headache was defined as 'any headache' (mild, moderate or severe) during the last 7 days of each feeding period.
If the trial continues to recruit the full 400 neonates eligible for analysis, the treatment effect will be deemed statistically significant if the test statistic for the primary analysis falls within the O'Brien Fleming rejection region defined by |Zr|=2.01.
For the primary analysis on pain and physical function, we used data from the primary follow-up time as defined in the individual studies, varying from three to 24 months.
After accruing the 200 and 300 neonates eligible for analysis, we will stop the trial for efficacy if the test statistic for the primary analysis (see below) falls within the O'Brien Fleming rejection region defined by |Zr|=2.96 or 2.36.
For the primary analysis, the diagnosis at inclusion was used to define the PSP and MSA strata.
Ideally the same kind of rigor as used for the primary analysis should be applied, that is, a priori planned analyses, including well defined hypotheses and endpoints.
