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Careless handling might also lead to issues

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"While we acknowledge your response that an abrupt shortening of the enrollment period led to challenges and mistakes, your response is inadequate because, regardless of the length of the enrollment period, you are still responsible for ensuring that subjects meet protocol-specified eligibility criteria before you enroll them into the study," said FDA

Overall loss of muscle mass ranged from 32-45% and none of the 10 experimental treatment groups experienced any significant changes in muscle mass when administered treatment

10.1016/S0006-8993(00)02373-8 349

Section symposium, Honolulu, Hawaii, 13:032 Veljaca M, Sladoljev P, Mildner B (2003) Tolerability and pharmacokinetics of PL 14736, a novel agent for treatment of ulcerative colitis, in healthy male volunteers