4.3.6. Study Products, Randomization, and Blinding
The active study product consisted of 1100 mg fish oil, 640 mg omega-3 FAs (300 mg EPA and 220 mg DHA) (dosed as 2 capsules), and 200 IU of vitamin D (VNP Active n-3 PUFA manufactured by Pfizer CH). The probiotic product contained 1.25 × 10Randomization and blinding were performed by team members not involved in the study. Thus, both participants and any study personnel who were in contact with participants were blinded. Blinding was maintained until the statistical analyses of the primary outcome parameter were completed. The randomization was generated using the Randlist software version 1.5 (datinf GmbH, Tübingen, Germany, available at randomisation.eu) and performed in blocks of four. Randomization numbers were sequentially noted on the study product containers. The study personnel handed over the lowest number available to females eligible for the study, and the highest number available to males eligible for the study. By doing so, an equal distribution of both sexes in the two arms was ensured.