Our results indicate that the overall incidence of PEM-related pulmonary toxicity is 3.5%, which is very similar to the incidence given in previous Japanese reports.
Last ,erroneous results of ER, PR and HER2 expression may affect the incidence, given that a 10% of false-negative rate and a 5% of false-positive rate were reported in ER expression, whereas a 4% of false-negative and false-positive cases were reported in HER2 [ 25].
Using statistical methods, we predict the epidemic incidence given that a detection of the pathogen has occurred for the first time, considering that the epidemic has an asymptomatic period between infection and symptom development.
"In cohort studies on acute disease without induction period and a short time of follow up, like outbreaks, the risk of disease can be estimated directly using the cumulative incidence given a fixed cohort with fixed period of follow up and a low fraction of drop-outs" [ 37].
Power calculations based on an one-sided alpha of 0.025, a statistical power of 90%, and the VTE incidence given above showed that approximately 90,000 women-years would be needed to show non-inferiority of DRSP/EE 24d versus "Other OCs".
Although similar to incidence rates reported from other countries without routine vaccination against N. meningitidis, S. pneumoniae, and Hib (3, 4, 10, 30 ), this value likely represents a lower limit estimate of the true disease incidence, given the inherent limitations of hospital-based surveillance.
Furthermore, results may be influenced by the fact that disease incidence given by the respondents was mainly based on estimations rather than on true numbers.
The estimates of incidence given in this study were based on a number of assumptions, as limited data were available.
The ratio of these to the true incidence gives a distribution of ascertainment probabilities, s, across all clinics.
The low incidence gives optimism that behaviors are changing and this will lead to further reductions in the HIV-1 infection rates.
Conversely, the relatively low HIV-1 incidence gives optimism that the burden of HIV-1 infection will decline in the near future, if the current HIV-1 prevention interventions are continued.
