Nutrients 2023 , 15 , 3466
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3. Results 3.1. Study Population
Three hundred and fifty subjects were screened for eligibility; out of them, 199 did not meet the inclusion criteria and 19 subjects were not able to be included due to other reasons (Figure 1). Thus, 132 subjects were randomized into the study; 66 were allocated to the LPHEAL9 group and 66 were allocated to the placebo intervention group. In the LPHEAL9 group, 65 of the subjects finished the study, while 64 finished in the placebo group (ITT population). The PP population consisted of 113 subjects: 56 subjects in the LPHEAL9 group and 57 in the placebo. The reasons for not being included in the LPHEAL9 PP population were one or several of the following: missed visit window ( n = 4), intake of <80% of the study product ( n = 2), did not return study product ( n =1),AE ( n =2), and intake of prohibited medication ( n = 2). In the placebo group, subjects were excluded from the PP population due to one or several of the following reasons: missed visit window ( n = 2), intake of <80% of the study product ( n = 1), did not return study product ( n =2), AE ( n = 2), pregnancy ( n = 1), and intake of prohibited medication ( n =2). 7 of 17
Nutrients 2023 , 15 , x FOR PEER REVIEW
Figure 1. Participant fl ow chart. Abbreviations: ITT, intention to treat; PP, per protocol; PI, primary investigator. The ratio between female/male were equal in both LPHEAL9 and placebo groups, 65% vs. 67%. The mean (min–max) age was 35.2 (21–52) years, and the BMI was 26.4 (19– 47) kg/m 2 (Table 1). Figure 1. Participant flow chart. Abbreviations: ITT, intention to treat; PP, per protocol; PI, primary investigator.
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