At 48 weeks post-repeat treatment, the mean NLF scores were 1.1 1.3 (mild), and 78 90% of subjects were considered responders (≥1 point improvement).
Furthermore, a full 78 90% of subjects were responders (≥1 point WAS improvement) at 48 weeks post-repeat treatment (Fig. 5), and the long-term results showed a smooth, natural looking wrinkle correction (Fig. 6).
Third, only a single iteration was performed in the TTO exercise, instead of a more common repeated choice ('ping-pong') exercise, which could have allowed for a more precise estimation of the responders' indifference point in the trade-off exercise, and to different results [ 28].
In the item-selection process, we performed item analysis to confirm that selected answers were not heavily weighted on either end of the 5-point scale (i.e. 80% or more responders selected points 0 and 1 or 4 and 5), and examined reproducibility with a weighted kappa coefficient to exclude items with κ value < 0.5.
In addition, we chose to look at the stool frequency responder end point included in a recent US Food and Drug Administration guidance document (20); "CSBM stool frequency responder" was defined as a patient who had an increase of ≥1 CSBM per week over baseline for at least 4 of the 8 weeks of the treatment period.
There was no significant difference between the fluoxetine and the placebo group in the proportion of responders (six points change).
Secondary endpoints included IPSS responders (≥25%, ≥2-point, and ≥3-point improvement), peak urinary flow rate, peak urinary flow rate responders (≥30% and ≥3 mL/s improvement), total prostate volume, and prostate transition zone volume.
Responder end points were analyzed using a Cochran Mantel–Haenszel (CMH) test controlling for geographic region.
His endorsement of studies that screen out placebo responders misses the point that our study aimed to estimate the difference between the effects of medications and placebos.
