paraphrase, "The primary outcome was change in HbA1c after 3-month follow-up. HbA1c was assessed centrally in an accredited laboratory, adhering to international criteria, set out according to International Organisation for Standardisation standards (ISO Standard 15,189:2012). HbA1c measurement was conducted using the turbidimetric inhibition immunoassay method, with a ROCHE COBAS intergra 400 plus analyser