Statistics Statistics The sample size estimation is performed using HGS as the primary endpoint. A clinically important difference was defined as a mean difference in HGS of 1 kg between baseline and follow up between the two treatment groups. Then, if the true mean difference in the intervention and control group in HGS between baseline and follow up is 1 kg with an estimated standard deviation of 1.8, the investigator will need to study a minimum of 52 patients in each treatment group, a total of 104 patients, considering a type I error of 5% and a power of 80%. Due to possible drop-outs the sample size will be increased with 20 %, which gives a total of 126 patients i.e. 63 patients in each group.