Statistical analysis
REMISSION
The primary analysis was based on the intention-to-treat allocation. The distribution of metric variables was characterized by reporting means and standard deviation or median and quartiles as appropriate. For dichotomous variables, absolute and relative frequencies were presented. The Mann–Whitney Kaplan–Meier curves were used to analyze time-to-event data, such as the time-to-remission. In this study, the curves plot the cumulative proportion of individuals who experience remission of GD over time. Log-rank testing was the statistical test used to compare the survival curves of the studied groups. Significant Economic analysis: An incremental cost-effectiveness analysis (ICER) was conducted to evaluate the costs and effectiveness of AZA. The analysis was performed from the perspective of the health sector, using Egyptian pounds (EGP) as the currency. The analysis considered all direct and indirect costs. Direct costs of AZA included medication costs, definitive treatment (including no medicine, surgery which cost 30000 EGP, or RAI which cost 8000 EGP), replacement treatment, investigations (which cost 565 EGP), and clinic visits (which cost 250 EGP). Indirect costs included the number of absenteeism days before returning to normal activities and work (multiplied by 100 EGP). The effectiveness of AZA was measured by the rate of remission. The total costs for each of the AZA1 and conventional groups were calculated by summing each individual patient’s cost. The ICER was calculated using the formula: ICER = (CA – Cc)/(EA – Ec), where CA is the cost of AZA until definitive treatment, Cc is the cost of conventional therapy until definitive treatment, EA is the rate of remission for AZA, and Ec is the rate of remission for conventional therapy.