Der blev fremlagt to randomiserede, dobbeltblinde hovedundersøgelser med parallelgrupper og fem understøttende undersøgelser til vurdering af effekten af lansoprazol til behandling af symptomatisk gastroøsofageal reflukssygdom.
The data do not support the indication “prevention of symptoms” nor “prophylaxis of gastroduodenal erosions”. • Symptomatic gastroesophageal reflux disease (4.1 and 4.2) Two pivotal randomised, double-blind, parallel-group trials and 5 supportive studies to evaluate the efficacy of lansoprazole for treatment of symptomatic gastroesophageal reflux disease were submitted.