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28) and remained unchanged at the studys end (both 27)

"We emphasize that as the clinical investigator, it is your responsibility to ensure that studies are conducted in accordance with the investigational plan, both to protect the rights, safety, and welfare of subjects and to ensure the integrity of study data." FDA noted that two of the nine randomized subjects who received the investigational product were not eligible under the enrollment criteria

The UVB irradiated group (index: 15.082 1.001) showed a significant increase in pigmentation index as compared with the vehicle control group (index: 3.621 0.442)