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With TSA, half the subgroup meta-analyses reached the futility area with the predefined minimal clinical difference and alpha and beta, while the other half did not report firm results Table 1.
Only the meta-analysis for the subgroup 701—1050 did not report firm evidence according to TSA Table 1. Of the 27 trials, 8 were classified as overall low risk of bias, 9, 41, 62, 76, 107, 128, 140 and these 8 trials reported more than half the SAEs.
The trials with overall low risk of bias reported the following SAEs: death, vein thrombosis, pneumonia, wound infection, admission to intensive care unit, and prolonged hospital stay. Owing to the variability in regular dosage frequency between the medications PGB twice daily, GBP thrice daily, study medication packs will contain three bottles each, correlating to the dosage times of morning, lunchtime and night, so as to maintain blinding.