Henrotin et al. BMC Musculoskeletal Disorders
(2022) 23:650
Page 4 of 11
withdrawn due to receiving a clinically abnormal blood result, and one participant was withdrawn due to a lack of study product, and two participants did not give rea- sons for their withdrawal. All other 198 participants completed the study as planned (Fig. 1). Two hundred three participants were included in the Safety population as they took at least one dose of the product, 198 participants were considered eligi- ble for the ITT analysis. Among the Safety population, 68 participants received a placebo, 69 RIE 200 mg, and 66 RIE 400 mg. The number of withdrawals was 2 in the placebo group, 2 in the RIE 200 mg group, and 5 in the 400 mg group (Fig. 1; Additional file 1). At baseline, participants in each group were well-matched (Table 1). Females and males were equally distributed among the three groups. 68.7% in RIE 400 mg, 74.3% in RIE 200 mg, and 70.6% of placebo participants were overweight or obese (BMI ≥ 25 kg/m2). All participants had a diagno- sis of OA. 53% had a Kellgren-Lawrence score of 1 and 38% had a Kellgren-Lawrence score of 2. The remaining
treatment x visit interaction. The adequacy of the model was verified by residuals analysis. Normality distribution of the residuals was verified by Skewness and Kurtosis (less than 2 in absolute value). Data presented were the mean and standard error model (SEM). All tests of sig- nificance were completed at α = 0.05, two-tailed. Dun- nett corrections were performed to adjust the p-value for multiple comparisons (active treatment group versus a placebo group). Results Population A total of 208 participants (74 men and 124 female) were randomly assigned to treatment on a 1:1:1 basis, where n = 70 participants were allocated to the Placebo arm, n = 69 participants were allocated to the 200 mg RIE arm, and n = 69 participants were allocated to the 400 mg RIE arm. Nine participants withdrew prematurely from the study, five of these were withdrawn due to an adverse event/Severe Adverse Event (SAE), one participant was
Fig. 1 Flow diagram of RUBUS study
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