“…In most trials, patients under placebo have a mean improvement of RQLQ around 1 point [9,23,24,[27][28][29], we therefore considered a score change of 1 point as a clinically significant change of RQLQ. The TSS6 was considered to be improved if patients had a 50% change in symptoms improvement [28][29][30][31][32][33][34]. The baseline TSS6 was close to 10 in our study and we considered an a priori change of 5 points, on a scale ranging from 0 to 18, as a clinically relevant improvement of symptoms.…”