FDA label 93b5a881-fb03-4650-ad1c-a18bd7bc8a10

5 WARNINGS AND PRECAUTIONS Routine monitoring of renal and hepatic function is recommended in patients receiving lPN, particularly in those with renal or hepatic impairment ( 5.1 ) 5.1 Increased Serum Ammonia and Glutamate Glutamine is metabolized to glutamate and ammonia, which may increase in patients with hepatic dysfunction. Therefore, routine monitoring of renal and hepatic function is recommended in patients receiving intravenous parenteral nutrition (IPN) and NutreStore, particularly in those with renal or hepatic impairment.

6 ADVERSE REACTIONS Most common adverse reactions are ( 6.1 ): In initial four (4) weeks (incidence >10%): flatulence, abdominal pain, nausea, tenesmus, vomiting, hemorrhoids, mouth dry. In weeks 5-18 (incidence >10%): nausea, vomiting, tenesmus, pancreatitis, constipation, Crohn's disease aggravated, gastric ulcer, gastrointestinal fistula. To report SUSPECTED ADVERSE REACTIONS, contact Emmaus Medical, Inc. at 1-877-420-6493 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice Table 1 provides the number of subjects by system-organ class experiencing at least one adverse reaction during the 4-week treatment period of the SBS study. To be listed in Table 1, an adverse reaction must have occurred in more than 10% of subjects in any treatment group. Table 1 Controlled Trial Adverse Reactions - Initial 4 Week Treatment Period Adverse Reactions Group A Group B Group C rhGH+SOD SOD [GLN) = Specialized Oral Diet supplemented with Glutamine; rhGH + SOD = Human Growth Hormone plus Specialized Oral Diet; rhGH + SOD [GLN] = Human Growth Hormone plus Specialized Oral Diet supplemented with Glutamine N=16 n (%) rhGH+SOD[GLN] N=16 n (%) SOD[GLN] N=9 n (%) GROUP A: rhGH + SOD for 4 weeks followed by SOD for 12 weeks. GROUP B: rhGH + SOD [GLN] for 4 weeks followed by SOD [GLN] for 12 weeks. GROUP C: rhGH placebo + SOD [GLN] for 4 weeks followed by SOD [GLN) for 12 weeks. Total Number of Subjects with At Least One Adverse Reaction 16 (100) 16 (100) 8 (89) Body as a Whole: General Disorders 15 (94) 15 (94) 4 (44) Edema, Peripheral 11 (69) 13 (81) 1 (11) Edema, Facial 8 (50) 7 (44) 0(0) Pain 3 (19) 1 (6) 1 (11) Chest Pain 3 (19) 0 (0) 0 (0) Fever 0 (0) 1 (6) 2 (22) Back Pain 1 (6) 0 (0) 1 (11) Flu-like Disorder 0 (0) 1 (6) 1 (11) Malaise 2 (13) 0 (0) 0 (0) Edema, Generalized 2 (13) 0 (0) 0 (0) Abdomen Enlarged 0 (0) 0 (0) 1 (11) Allergic Reaction 0 (0) 0 (0) 1 (11) Rigors (Chills) 0 (0) 0 (0) 1 (11) Gastrointestinal System Disorders 12 (75) 12 (75) 6 (67) Flatulence 4 (25) 4 (25) 2 (22) Abdominal Pain 4 (25) 2 (13) 1 (11) Nausea 2 (13) 5 (31) 0 (0) Tenesmus 1 (6) 3 (19) 3 (33) Vomiting 3 (19) 3 (19) 1 (11) Hemorrhoids 1 (6) 0 (0) 1 (11) Mouth Dry 1 (6) 0 (0) 1(11) Musculoskeletal System Disorders 7 (44) 7 (44) 1 (11) Arthralgia 7(44) 5 (31) 0 (0) Myalgia 2 (13) 0 (0) 1 (11) Resistance Mechanism Disorders 6 (38) 3 (19) 4 (44) Infection 0 (0) 1 (6) 3 (33) Infection Bacterial 3 (19) 0 (0) 1 (11) Infection Viral 1 (6) 2 (13) 0 (0) Moniliasis 2 (13) 0 (0) 0 (0) Application Site Disorders 5 (31) 4 (25) 1 (11) Injection Site Reaction 3 (19) 4 (25) 1 (11) Injection Site Pain 5 (31) 0 (0) 0 (0) Central and Peripheral Nervous System Disorders 4 (25) 4 (25) 2 (22) Dizziness 1 (6) 2 (13) 0 (0) Headache 1 (6) 1 (6) 1 (11) Hypoasthesia 1 (6) 1 (6) 1 (11) Skin and Appendages Disorders 4 (25) 4 (25) 2 (22) Rash 1 (6) 2 (13) 0 (0) Pruritis 0 (0) 1 (6) 1 (11) Sweating Increased 2 (13) 0 (0) 0 (0) Nail Disorder 0 (0) 0 (0) 1 (11) Respiratory System Disorders 1 (6) 5 (31) 1 (11) Rhinitis 0 (0) 3 (19) 1 (11) Metabolic and Nutritional Disorders 3 (19) 1 (6) 1 (11) Dehydration 3 (19) 0 (0) 1 (11) Thirst 0 (0) 0 (0) 1 (11) Urinary System Disorders 2 (13) 1 (16) 1 (11) Pyelonephritis 0 (0) 0 (0) 1 (11) Psychiatric Disorders 1 (6) 0 (0) 2 (22) Depression 0 (0) 0 (0) 2 (22) Reproductive Disorders, Female 2 (13) 0 (0) 1 (11) Breast Pain Female 1 (6) 0 (0) 1 (11) Hearing and Vestibular Disorders 0 (0) 2 (13) 0 (0) Ear or Hearing Symptoms 0 (0) 2 (13) 0 (0) Table 2 summarizes the number of subjects by system-organ class who experienced an AR during weeks 5 to 18 of the randomized, controlled SBS study. To be listed in Table 2, an AR must have occurred in more than 10% of subjects in any treatment group. Table 2 Controlled Trial Adverse Reactions -Weeks 5 to 18 Adverse Reactions Group A Group B Group C rhGH+SOD SOD [GLNJ = Specialized Oral Diet supplemented with Glutamine; rhGH + SOD = Human Growth Hormone plus Specialized Oral Diet; rhGH + SOD [GLN] = Human Growth Hormone plus Specialized Oral N=15 n (%) rhGH+SOD[GLN] N=16 n (%) SOD[GLN] N=9 n (%) GROUP A: rhCH + SOD for 4 weeks followed by SOD for 12 weeks. GROUP B: rhGH + SOD [GLN] for 4 weeks followed by SOD [GLN] for 12 weeks. GROUP C: rhGH placebo + SOD [GLN] for 4 weeks followed by SOD [GLN] for 12 weeks. Total Number of Subjects with At Least One Adverse Reaction 12 (80) 13 (81) 7 (78) Gastrointestinal System Disorders 7 (47) 7 (44) 3 (33) Nausea 3 (20) 0 (0) 2 (22) Vomiting 2 (13) 3 (19) 0 (0) Abdominal Pain 3 (20) 1 (6) 0 (0) Tenesmus 0 (0) 3 (19) 1 (11) Pancreatitis 0 (0) 1 (6) 1 (11) Constipation 0 (0) 0 (0) 1 (11) Crohn's Disease Aggravated 0 (0) 0 (0) 1 (11) Gastric Ulcer 0 (0) 0 (0) 1 (11) Gastrointestinal FistuIa 0 (0) 0 (0) 1 (11) Resistance Mechanism Disorders 6 (40) 5 (31) 5 (56) Infection Bacterial 0 (0) 2 (13) 3 (33) Infection Viral 3 (20) 1 (6) 1 (11) Infection 1 (7) 2 (13) 1 (11) Sepsis 3 (20) 1 (6) 0 (0) Body as a Whole: General Disorders 4 (27) 2 (13) 1 (11) Fever 2 (13) 1 (6) 1 (11) Fatigue 2 (13) 0 (0) 0 (0) Respiratory System Disorders 2 (13) 4 (25) 1 (11) Rhinitis 1 (7) 3 (19) 0 (0) Laryngitis 0 (0) 0 (0) 1 (11) Pharyngitis 0 (0) 0 (0) 1 (11) Reproductive Disorders, Female 0 (0) 4 (25) 1 (11) Vaginal Fungal Infection 0 (0) 0 (0) 1 (11) Skin and Appendages Disorders 2 (13) 2 (13) 1 (11) Rash 1 (7) 0 (0) 1 (11) Musculoskeletal System Disorders 2 (13) 2 (13) 0 (0) Arthralgia 2 (13) 2 (13) 0 (0) Psychiatric Disorders 0 (0) 1 (6) 1 (11) Depression 0 (0) 0 (0) 1 (11) Insomnia 0 (0) 0 (0) 1 (11) Urinary System Disorders 0 (0) 0 (0) 2 (22) Pyelonephritis 0 (0) 0 (0) 1 (11) Renal Calculus 0 (0) 0 (0) 1 (11) Application Site Disorders 0 (0) 0 (0) 1 (11) Injection Site Reaction 0 (0) 0 (0) 1 (11) Liver and Biliary System Disorders 0 (0) 0 (0) 1 (11) Hepatic Function Abnormal 0 (0) 0 (0) 1 (11) Vascular Extracardiac Disorders 0 (0) 0 (0) 1 (11) Vascular Disorder 0 (0) 0 (0) 1 (11) During the initial 4-week treatment period, 100% of patients receiving growth hormone with and without glutamine reported at least one AR, whereas 89% of patients receiving growth hormone placebo with glutamine reported at least one AR. During weeks 5 to 18, 81% of patients receiving growth hormone with glutamine, 80% of patients receiving growth hormone without glutamine and 78% of patients receiving growth hormone placebo with glutamine experienced at least one AR. There were no deaths in this study.

<table width="100%"> <caption>Table 1 Controlled Trial Adverse Reactions - Initial 4 Week Treatment Period</caption> <col width="50%" align="left" valign="top"/> <col width="15%" align="center" valign="top"/> <col width="20%" align="center" valign="top"/> <col width="15%" align="center" valign="top"/> <thead> <tr> <th styleCode="Lrule Rrule" align="center">Adverse Reactions</th> <th styleCode="Rrule">Group A</th> <th styleCode="Rrule">Group B</th> <th styleCode="Rrule">Group C</th> </tr> <tr> <th styleCode="Lrule Rrule"/> <th styleCode="Rrule">rhGH+SOD<footnote ID="table1a">SOD [GLN) = Specialized Oral Diet supplemented with Glutamine; rhGH + SOD = Human Growth Hormone plus Specialized Oral Diet; rhGH + SOD [GLN] = Human Growth Hormone plus Specialized Oral Diet supplemented with Glutamine</footnote> N=16 n (%)</th> <th styleCode="Rrule">rhGH+SOD[GLN]<footnoteRef IDREF="table1a"/> N=16 n (%)</th> <th styleCode="Rrule">SOD[GLN]<footnoteRef IDREF="table1a"/> N=9 n (%)</th> </tr> </thead> <tfoot> <tr> <td colspan="4" align="left">GROUP A: rhGH + SOD for 4 weeks followed by SOD for 12 weeks.</td> </tr> <tr> <td colspan="4" align="left">GROUP B: rhGH + SOD [GLN] for 4 weeks followed by SOD [GLN] for 12 weeks.</td> </tr> <tr> <td colspan="4" align="left">GROUP C: rhGH placebo + SOD [GLN] for 4 weeks followed by SOD [GLN) for 12 weeks.</td> </tr> </tfoot> <tbody> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Total Number of Subjects with At Least One Adverse Reaction</content> </td> <td styleCode="Rrule">16 (100)</td> <td styleCode="Rrule">16 (100)</td> <td styleCode="Rrule">8 (89)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Body as a Whole: General Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">15 (94)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">15 (94)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">4 (44)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Edema, Peripheral</td> <td styleCode="Rrule">11 (69)</td> <td styleCode="Rrule">13 (81)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Edema, Facial</td> <td styleCode="Rrule">8 (50)</td> <td styleCode="Rrule">7 (44)</td> <td styleCode="Rrule">0(0)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Pain</td> <td styleCode="Rrule">3 (19)</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Chest Pain</td> <td styleCode="Rrule">3 (19)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Fever</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">2 (22)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Back Pain</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Flu-like Disorder</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Malaise</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Edema, Generalized</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Abdomen Enlarged</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Allergic Reaction</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Rigors (Chills)</td> <td styleCode="Rrule">0 (0) </td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Gastrointestinal System Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">12 (75)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">12 (75)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">6 (67)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Flatulence</td> <td styleCode="Rrule">4 (25)</td> <td styleCode="Rrule"> 4 (25)</td> <td styleCode="Rrule">2 (22)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Abdominal Pain</td> <td styleCode="Rrule">4 (25)</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Nausea</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">5 (31)</td> <td styleCode="Rrule">0 (0)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Tenesmus</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">3 (19)</td> <td styleCode="Rrule">3 (33)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Vomiting</td> <td styleCode="Rrule">3 (19)</td> <td styleCode="Rrule">3 (19)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Hemorrhoids</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Mouth Dry</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1(11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Musculoskeletal System Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">7 (44)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">7 (44)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">1 (11)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Arthralgia</td> <td styleCode="Rrule">7(44)</td> <td styleCode="Rrule">5 (31)</td> <td styleCode="Rrule">0 (0)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Myalgia</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Resistance Mechanism Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">6 (38)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">3 (19)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">4 (44)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Infection</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">3 (33)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Infection Bacterial</td> <td styleCode="Rrule">3 (19)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Infection Viral</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">0 (0)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Moniliasis</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Application Site Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">5 (31)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">4 (25)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">1 (11)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Injection Site Reaction</td> <td styleCode="Rrule">3 (19)</td> <td styleCode="Rrule">4 (25)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Injection Site Pain</td> <td styleCode="Rrule">5 (31)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Central and Peripheral Nervous System Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">4 (25)</content> </td> <td styleCode="Rrule"> <content styleCode="bold"> 4 (25)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">2 (22)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Dizziness</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">0 (0)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Headache</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Hypoasthesia</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Skin and Appendages Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">4 (25)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">4 (25)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">2 (22)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Rash</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">0 (0)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Pruritis</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Sweating Increased</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Nail Disorder</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Respiratory System Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">1 (6)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">5 (31)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">1 (11)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Rhinitis</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">3 (19)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Metabolic and Nutritional Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">3 (19)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">1 (6)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">1 (11)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Dehydration</td> <td styleCode="Rrule">3 (19)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Thirst</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Urinary System Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">2 (13)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">1 (16)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">1 (11)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Pyelonephritis</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Psychiatric Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">1 (6)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">0 (0)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">2 (22)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Depression</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">2 (22)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Reproductive Disorders, Female</content> </td> <td styleCode="Rrule"> <content styleCode="bold">2 (13)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">0 (0)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">1 (11)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Breast Pain Female</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Hearing and Vestibular Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">0 (0)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">2 (13)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">0 (0)</content> </td> </tr> <tr> <td styleCode="Lrule Rrule"> Ear or Hearing Symptoms</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">0 (0)</td> </tr> </tbody> </table>

<table width="100%"> <caption>Table 2 Controlled Trial Adverse Reactions -Weeks 5 to 18</caption> <col width="50%" align="left" valign="top"/> <col width="15%" align="center" valign="top"/> <col width="20%" align="center" valign="top"/> <col width="15%" align="center" valign="top"/> <thead> <tr> <th styleCode="Lrule Rrule" align="center">Adverse Reactions</th> <th styleCode="Rrule">Group A</th> <th styleCode="Rrule">Group B</th> <th styleCode="Rrule">Group C</th> </tr> <tr> <th styleCode="Lrule Rrule"/> <th styleCode="Rrule">rhGH+SOD<footnote ID="table2a">SOD [GLNJ = Specialized Oral Diet supplemented with Glutamine; rhGH + SOD = Human Growth Hormone plus Specialized Oral Diet; rhGH + SOD [GLN] = Human Growth Hormone plus Specialized Oral</footnote> N=15 n (%)</th> <th styleCode="Rrule">rhGH+SOD[GLN]<footnoteRef IDREF="table2a"/> N=16 n (%)</th> <th styleCode="Rrule">SOD[GLN]<footnoteRef IDREF="table2a"/> N=9 n (%)</th> </tr> </thead> <tfoot> <tr> <td colspan="4" align="left">GROUP A: rhCH + SOD for 4 weeks followed by SOD for 12 weeks.</td> </tr> <tr> <td colspan="4" align="left">GROUP B: rhGH + SOD [GLN] for 4 weeks followed by SOD [GLN] for 12 weeks.</td> </tr> <tr> <td colspan="4" align="left">GROUP C: rhGH placebo + SOD [GLN] for 4 weeks followed by SOD [GLN] for 12 weeks.</td> </tr> </tfoot> <tbody> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Total Number of Subjects with At Least One Adverse Reaction</content> </td> <td styleCode="Rrule" valign="bottom"> <content styleCode="bold">12 (80)</content> </td> <td styleCode="Rrule" valign="bottom"> <content styleCode="bold">13 (81)</content> </td> <td styleCode="Rrule" valign="bottom"> <content styleCode="bold">7 (78)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Gastrointestinal System Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">7 (47)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">7 (44)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">3 (33)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Nausea</td> <td styleCode="Rrule">3 (20)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">2 (22)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Vomiting</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">3 (19)</td> <td styleCode="Rrule">0 (0)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Abdominal Pain</td> <td styleCode="Rrule">3 (20)</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">0 (0)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Tenesmus</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">3 (19)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Pancreatitis</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Constipation</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Crohn&apos;s Disease Aggravated</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Gastric Ulcer</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Gastrointestinal FistuIa</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Resistance Mechanism Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">6 (40)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">5 (31)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">5 (56)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Infection Bacterial</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">3 (33)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Infection Viral</td> <td styleCode="Rrule">3 (20)</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Infection</td> <td styleCode="Rrule">1 (7)</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Sepsis</td> <td styleCode="Rrule">3 (20)</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">0 (0)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Body as a Whole: General Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">4 (27)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">2 (13)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">1 (11)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Fever</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">1 (6)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Fatigue</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Respiratory System Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">2 (13)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">4 (25)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">1 (11)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Rhinitis</td> <td styleCode="Rrule">1 (7)</td> <td styleCode="Rrule">3 (19)</td> <td styleCode="Rrule">0 (0)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Laryngitis</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Pharyngitis</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Reproductive Disorders, Female</content> </td> <td styleCode="Rrule"> <content styleCode="bold">0 (0)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">4 (25)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">1 (11)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Vaginal Fungal Infection</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">Skin and Appendages Disorders</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Rash</td> <td styleCode="Rrule">1 (7)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Musculoskeletal System Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">2 (13)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">2 (13)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">0 (0)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Arthralgia</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">2 (13)</td> <td styleCode="Rrule">0 (0)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Psychiatric Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">0 (0)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">1 (6)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">1 (11)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Depression</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Insomnia</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Urinary System Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">0 (0)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">0 (0)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">2 (22)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Pyelonephritis</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Renal Calculus</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Application Site Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">0 (0)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">0 (0)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">1 (11)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Injection Site Reaction</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Liver and Biliary System Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">0 (0)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">0 (0)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">1 (11)</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> Hepatic Function Abnormal</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule"> <content styleCode="bold">Vascular Extracardiac Disorders</content> </td> <td styleCode="Rrule"> <content styleCode="bold">0 (0)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">0 (0)</content> </td> <td styleCode="Rrule"> <content styleCode="bold">1 (11)</content> </td> </tr> <tr> <td styleCode="Lrule Rrule"> Vascular Disorder</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">0 (0)</td> <td styleCode="Rrule">1 (11)</td> </tr> </tbody> </table>