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Non-oral contraception or backup contraceptive methods are recommended for 4 weeks after initiation and with each dose increase

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For the primary analysis, aITCs were based on results for the efficacy estimand (referred to as the trial product estimand in SUSTAIN FORTE), which was defined as the treatment effect among all patients who underwent randomization and received at least one dose of the study medication, excluding the data after the start of rescue therapy (for persistent hyperglycaemia) or study drug discontinuation