FOUNDAYO

WARNING: RISK OF THYROID C-CELL TUMORS In products with glucagon-like peptide-1 (GLP-1) receptor agonist activity that are pharmacologically active in rats and mice, rodent thyroid C-cell tumors (adenomas and carcinomas) have been observed at clinically relevant exposures and are considered GLP-1 receptor-dependent effects in rodents. Orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents [see Nonclinical Toxicology ( 13.1 )] . While orforglipron is pharmacologically active at the human GLP-1 receptor, the human relevance of GLP-1 receptor-dependent thyroid C-cell tumors observed in rodents has not been determined [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 )] . FOUNDAYO is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications ( 4 )] . Counsel patients regarding the potential risk for MTC with the use of FOUNDAYO and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with FOUNDAYO [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. In products with glucagon-like peptide-1 (GLP-1) receptor agonist activity that are pharmacologically active in rats and mice, rodent thyroid C-cell tumors (adenomas and carcinomas) have been observed at clinically relevant exposures and are considered GLP-1 receptor-dependent effects in rodents. Orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents ( 13.1 ) . While orforglipron is pharmacologically active at the human GLP-1 receptor, the human relevance of GLP-1 receptor-dependent thyroid C-cell tumors observed in rodents has not been determined ( 5.1 , 13.1 ). FOUNDAYO is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors ( 4 , 5.1 ).

5 WARNINGS AND PRECAUTIONS Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including FOUNDAYO. Discontinue if pancreatitis is suspected. ( 5.2 ) Severe Gastrointestinal Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. FOUNDAYO is not recommended in patients with severe gastroparesis. ( 5.3 ) Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.4 ) Hypoglycemia: Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dosage of insulin or insulin secretagogue may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. ( 5.5 ) Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with GLP-1 receptor agonists. If suspected, advise the patient to promptly seek medical attention and discontinue FOUNDAYO. ( 5.6 ) Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has not been studied in patients with diabetic retinopathy and/or macular edema requiring acute treatment. Monitor patients with a history of diabetic retinopathy for progression. ( 5.7 ) Acute Gallbladder Disease : Has been reported in clinical trials. If cholecystitis is suspected, gallbladder studies and clinical follow-up are indicated. ( 5.8 ) Pulmonary Aspiration During General Anesthesia and Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures. ( 5.9 ) 5.1 Risk of Thyroid C-Cell Tumors In products with GLP-1 receptor agonist activity that are pharmacologically active in rats and mice, rodent thyroid C-cell tumors (adenomas and carcinomas) have been observed at clinically relevant exposures and are considered GLP-1 receptor-dependent effects in rodents. Orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents [see Nonclinical Toxicology ( 13.1 )] . While orforglipron is pharmacologically active at the human GLP-1 receptor, the human relevance of GLP-1 receptor-dependent thyroid C-cell tumors observed in rodents has not been determined [see Nonclinical Toxicology ( 13.1 )] . Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans. FOUNDAYO is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of FOUNDAYO and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, or persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with FOUNDAYO. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated. 5.2 Acute Pancreatitis Acute pancreatitis has been reported in patients treated with FOUNDAYO. Fatal and non-fatal hemorrhagic or necrotizing pancreatitis have been observed in patients treated with GLP-1 receptor agonists [see Adverse Reactions ( 6 )] . After initiation of FOUNDAYO, observe patients carefully for signs and symptoms of acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back) and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue FOUNDAYO and initiate appropriate management. 5.3 Severe Gastrointestinal Reactions Use of FOUNDAYO has been associated with gastrointestinal adverse reactions, sometimes severe. In clinical trials, severe gastrointestinal adverse reactions were reported more frequently among patients treated with orforglipron (approximately 3%) than patients who received placebo (1%). Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists [see Adverse Reactions ( 6 )] . FOUNDAYO is not recommended in patients with severe gastroparesis. 5.4 Acute Kidney Injury Due to Volume Depletion There have been reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists or FOUNDAYO. The majority of the reported events occurred in patients who experienced gastrointestinal adverse reactions leading to dehydration such as nausea, vomiting, or diarrhea [see Adverse Reactions ( 6 )] . Monitor renal function in patients reporting adverse reactions to FOUNDAYO that could lead to volume depletion, especially during dosage initiation and escalation of FOUNDAYO. 5.5 Hypoglycemia FOUNDAYO lowers blood glucose and can cause hypoglycemia. In a trial of adults with type 2 diabetes and BMI ≥27 kg/m 2 (Trial 2), hypoglycemia (plasma glucose <54 mg/dL) was reported in 2% of patients treated with orforglipron versus 0.2% of patients receiving placebo. One patient treated with orforglipron and no patients receiving placebo reported severe hypoglycemia in Trial 2. In Trial 2, 7% of patients treated with orforglipron once daily in combination with sulfonylurea reported hypoglycemia compared with 0.5% of patients not taking a sulfonylurea [see Adverse Reactions ( 6.1 )] . There is also increased risk of hypoglycemia in patients treated with FOUNDAYO in combination with insulin [see Drug Interactions ( 7.2 )] . Hypoglycemia has also been associated with FOUNDAYO and GLP-1 receptor agonists in adults without type 2 diabetes [see Adverse Reactions ( 6.1 )] . Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. In patients with diabetes, monitor blood glucose prior to starting FOUNDAYO and during FOUNDAYO treatment. The risk of hypoglycemia may be lowered by a reduction in the dose of insulin or sulfonylurea (or other concomitantly administered insulin secretagogue). 5.6 Hypersensitivity Reactions Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with GLP-1 receptor agonists [see Adverse Reactions ( 6.2 )] . If hypersensitivity reactions occur, advise the patient to promptly seek medical attention and discontinue use of FOUNDAYO. FOUNDAYO is contraindicated in patients with a prior serious hypersensitivity reaction to orforglipron or to any of the excipients in FOUNDAYO. Use caution in a patient with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to these reactions with FOUNDAYO. 5.7 Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Temporary worsening of diabetic retinopathy has been reported with rapid improvement in glucose control. FOUNDAYO has not been studied in patients with diabetic retinopathy and/or macular edema requiring acute treatment. Monitor patients with a history of diabetic retinopathy for progression of diabetic retinopathy. 5.8 Acute Gallbladder Disease Treatment with FOUNDAYO and GLP-1 receptor agonists is associated with an increased occurrence of acute gallbladder disease. In a pool of two clinical trials for weight reduction (Trials 1 and 2), cholelithiasis was reported in 1% of patients treated with orforglipron once daily and 0.7% of placebo-treated patients, and acute cholecystitis was reported in 0.4% of patients treated with orforglipron once daily and 0.3% of placebo-treated patients [see Adverse Reactions ( 6 )] . Acute gallbladder events were associated with weight reduction. If cholecystitis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated. 5.9 Pulmonary Aspiration During General Anesthesia or Deep Sedation FOUNDAYO delays gastric emptying [see Clinical Pharmacology ( 12.2 )] . There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations. Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking FOUNDAYO, including whether modifying preoperative fasting recommendations or temporarily discontinuing FOUNDAYO could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking FOUNDAYO.

6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: Risk of Thyroid C-Cell Tumors [see Warnings and Precautions ( 5.1 )] Acute Pancreatitis [see Warnings and Precautions ( 5.2 )] Severe Gastrointestinal Reactions [see Warnings and Precautions ( 5.3 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.4 )] Hypoglycemia [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] Diabetic Retinopathy Complications in Patients with Type 2 Diabetes [see Warnings and Precautions ( 5.7 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.8 )] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] Most common adverse reactions, reported in ≥5% of patients treated with FOUNDAYO, are nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, eructation, gastroesophageal reflux disease, flatulence, and hair loss. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) 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 practice. The safety of FOUNDAYO has been established in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition based on adequate and well-controlled trials of an investigational orforglipron formulation (Trials 1 and 2), referred to in this section as FOUNDAYO [see Clinical Studies ( 14 )] . This section of labeling presents safety data from administration of the investigational orforglipron formulation shown as equivalent dosages of once daily FOUNDAYO [see Dosage and Administration ( 2.1 )] . Adverse Reactions in Patients in Weight Management Clinical Trials Pool of Two Placebo-Controlled Clinical Trials: FOUNDAYO was evaluated for safety in a pool of two randomized, double-blind, placebo-controlled trials that included 3155 adult patients with obesity or overweight treated with FOUNDAYO once daily for up to 72 weeks and a 2-week off-drug follow-up period (Trial 1 and Trial 2) [see Clinical Studies ( 14 )] . The mean age of patients was 49 years and 41% were male. The population was 60% White, 25% Asian, 8% Black or African American, and 0.3% American Indian or Alaska Native; 35% identified as Hispanic or Latino ethnicity. At baseline, patients had an average BMI of 36.5 kg/m 2 , 51% with a BMI ≥35 kg/m 2 , 50% with hypertension, 49% with dyslipidemia, 31% with type 2 diabetes, 11% with obstructive sleep apnea, 3% with coronary artery disease, and 3% with cerebrovascular disease. Across both trials, 8% of patients treated with FOUNDAYO (5.5 mg, 6%; 9 mg, 9%; and 17.2 mg, 10%) once daily permanently discontinued treatment as a result of adverse reactions compared to 3% of patients receiving placebo. The majority of patients (5%) who discontinued FOUNDAYO due to adverse reactions did so due to gastrointestinal adverse reactions. Common Adverse Reactions Table 1 shows common adverse reactions associated with the use of once daily FOUNDAYO in the pool of two placebo-controlled trials for weight management (Trials 1 and 2). These adverse reactions occurred more commonly with once daily FOUNDAYO than with placebo and occurred in at least 5% of patients treated with FOUNDAYO. Table 1: Adverse Reactions Reported in ≥5% of FOUNDAYO-treated Adult Patients with Obesity or Overweight (With or Without Type 2 Diabetes) in Pool of Placebo-Controlled Trials (Trials 1 and 2) a Includes other related terms. Adverse Reaction Placebo (N=1,576) % FOUNDAYO 5.5 mg once daily (N=1,051) % FOUNDAYO 9 mg once daily (N=1,055) % FOUNDAYO 17.2 mg once daily (N=1,049) % Nausea 10 26 34 35 Constipation 9 20 27 24 Diarrhea 11 21 23 25 Vomiting 4 13 21 24 Dyspepsia 4 12 16 13 Abdominal pain a 7 13 14 14 Headache 7 8 9 9 Abdominal distension 3 7 9 8 Fatigue a 4 6 7 9 Eructation 1 6 8 8 Gastroesophageal reflux disease 2 6 6 7 Flatulence 2 5 6 6 Hair loss a 2 4 4 5 Gastrointestinal Adverse Reactions In a pool of Trials 1 and 2, gastrointestinal adverse reactions occurred more frequently among patients treated with once daily FOUNDAYO 5.5 mg (60%), 9 mg (68%), and 17.2 mg (69%) than placebo (37%). More patients treated with once daily FOUNDAYO 5.5 mg (3%), 9 mg (6%), and 17.2 mg (6%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.7%). Of the FOUNDAYO-treated patients who reported GI adverse reactions, 60%, 36%, and 4% reported mild or moderate or severe adverse reactions, respectively. The incidence of nausea, vomiting, and diarrhea was higher during the FOUNDAYO dosage escalation period and decreased over time. Hypoglycemia In Trial 2, a trial of patients with type 2 diabetes and BMI ≥27 kg/m 2 , hypoglycemia (glucose <54 mg/dL) was reported in 2% of FOUNDAYO-treated patients versus 0.2% of placebo-treated patients. One patient treated with FOUNDAYO 5.5 mg once daily, and no patients receiving placebo reported severe hypoglycemia in Trial 2. In this trial, 7% of patients taking FOUNDAYO in combination with sulfonylurea reported hypoglycemia compared with 0.5% of patients not taking sulfonylurea. In Trial 1, a trial of FOUNDAYO in adults with BMI ≥27 kg/m 2 without type 2 diabetes, there was no systematic capturing of hypoglycemia, but glucose <54 mg/dL was reported in 0.6% of FOUNDAYO-treated patients and no placebo-treated patients. No patients in Trial 1 reported severe hypoglycemia. Other Adverse Reactions Acute Pancreatitis In a pool of Trials 1 and 2, 6 events of acute pancreatitis were confirmed by adjudication in 6 FOUNDAYO-treated patients (0.14 patients per 100 years of exposure) versus 2 events in 1 placebo-treated patient (0.04 patients per 100 years of exposure). Acute Kidney Injury In a pool of Trials 1 and 2, acute kidney injury was reported in 0.2% of FOUNDAYO-treated patients compared to 0.05% of placebo-treated patients. Hypotension In a pool of Trials 1 and 2, hypotension occurred more frequently among patients taking FOUNDAYO (2%) than patients taking placebo (0.5%). Hypotension was more frequently seen in FOUNDAYO-treated patients on concomitant antihypertensive therapy (4%) compared to FOUNDAYO-treated patients not on antihypertensive therapy (1%). Acute Gallbladder Disease In a pool of Trials 1 and 2, cholelithiasis was reported in 1% of FOUNDAYO-treated patients and 0.7% of placebo-treated patients, and acute cholecystitis was reported in 0.4% of FOUNDAYO-treated patients and 0.3% of placebo-treated patients. Tachycardia In a pool of Trials 1 and 2, tachycardia (tachycardia, heart rate increased, and sinus tachycardia) was reported in 3% of patients treated with FOUNDAYO and 0.9% receiving placebo. Treatment with FOUNDAYO resulted in a mean increase in heart rate of 4 to 5 beats per minute from baseline compared to 0.5 beat per minute with placebo. Hair Loss Hair loss adverse reactions in FOUNDAYO-treated patients were associated with weight reduction. In a pool of Trials 1 and 2, hair loss was reported more frequently in female than male patients in the FOUNDAYO (7% female versus 0.9% male) and placebo (3% female versus 0.7% male) treatment groups. Dizziness In a pool of Trials 1 and 2, dizziness was reported in 4% of FOUNDAYO-treated patients and 3% of placebo-treated patients. Dysgeusia In a pool of Trials 1 and 2, dysgeusia was reported in 0.9% of FOUNDAYO-treated patients and 0.3% of placebo-treated patients. Dysesthesia In a pool of Trials 1 and 2, dysesthesia was reported in 0.3% and 1% of patients treated with FOUNDAYO 9 mg, and 17.2 mg, respectively, and 0.1% of patients receiving placebo. No patients taking FOUNDAYO 5.5 mg reported dysesthesia. Hypersensitivity Reactions In a pool of Trials 1 and 2, hypersensitivity reactions, including anaphylactic reaction, occurred in 0.5% of FOUNDAYO-treated patients compared to 0.3% of placebo-treated patients. Laboratory Abnormalities Amylase and Lipase Increase In a pool of Trials 1 and 2, treatment with FOUNDAYO resulted in mean increases from baseline in serum pancreatic amylase concentrations of 16% to 20% and serum lipase concentrations of 26% to 31%, compared to mean increases from baseline in serum pancreatic amylase of 3% and serum lipase of 4% in placebo-treated patients. The clinical significance of elevations in amylase or lipase with FOUNDAYO is unknown in the absence of other signs and symptoms of pancreatitis. 6.2 Postmarketing Experience The following adverse reactions have been reported during post-approval use of GLP-1 receptor agonists. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal Disorders: acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death; ileus, intestinal obstruction, severe constipation including fecal impaction Hypersensitivity: anaphylaxis, angioedema Pulmonary : Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation Renal and Urinary Disorders: acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis

<table ID="t1" width="100%"><caption>Table 1: Adverse Reactions Reported in &#x2265;5% of FOUNDAYO-treated Adult Patients with Obesity or Overweight (With or Without Type 2 Diabetes) in Pool of Placebo-Controlled Trials (Trials 1 and 2) </caption><col width="26.205%" align="left"/><col width="16.763%" align="left"/><col width="19.004%" align="left"/><col width="19.004%" align="left"/><col width="19.024%" align="left"/><tfoot><tr><td colspan="5" align="left" valign="top"><paragraph styleCode="footnote">^a Includes other related terms. </paragraph></td></tr></tfoot><tbody><tr><td align="left" valign="bottom" styleCode="Toprule Botrule Lrule Rrule"><content styleCode="bold">Adverse Reaction</content></td><td align="center" valign="bottom" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Placebo</content> <content styleCode="bold">(N=1,576)</content> <content styleCode="bold">%</content></td><td align="center" valign="bottom" styleCode="Toprule Botrule Rrule"><content styleCode="bold">FOUNDAYO</content> <content styleCode="bold">5.5 mg once daily</content> <content styleCode="bold">(N=1,051)</content> <content styleCode="bold">%</content></td><td align="center" valign="bottom" styleCode="Toprule Botrule Rrule"><content styleCode="bold">FOUNDAYO</content> <content styleCode="bold">9 mg once daily</content> <content styleCode="bold">(N=1,055)</content> <content styleCode="bold">%</content></td><td align="center" valign="bottom" styleCode="Toprule Botrule Rrule"><content styleCode="bold">FOUNDAYO</content> <content styleCode="bold">17.2 mg once daily</content> <content styleCode="bold">(N=1,049)</content> <content styleCode="bold">%</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Nausea </td><td align="center" valign="middle" styleCode="Botrule Rrule">10 </td><td align="center" valign="top" styleCode="Botrule Rrule">26 </td><td align="center" valign="top" styleCode="Botrule Rrule">34 </td><td align="center" valign="top" styleCode="Botrule Rrule">35 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Constipation </td><td align="center" valign="middle" styleCode="Botrule Rrule">9 </td><td align="center" valign="top" styleCode="Botrule Rrule">20 </td><td align="center" valign="top" styleCode="Botrule Rrule">27 </td><td align="center" valign="top" styleCode="Botrule Rrule">24 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Diarrhea </td><td align="center" valign="middle" styleCode="Botrule Rrule">11 </td><td align="center" valign="top" styleCode="Botrule Rrule">21 </td><td align="center" valign="top" styleCode="Botrule Rrule">23 </td><td align="center" valign="top" styleCode="Botrule Rrule">25 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Vomiting </td><td align="center" valign="middle" styleCode="Botrule Rrule">4 </td><td align="center" valign="top" styleCode="Botrule Rrule">13 </td><td align="center" valign="top" styleCode="Botrule Rrule">21 </td><td align="center" valign="top" styleCode="Botrule Rrule">24 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Dyspepsia </td><td align="center" valign="middle" styleCode="Botrule Rrule">4 </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td><td align="center" valign="top" styleCode="Botrule Rrule">16 </td><td align="center" valign="top" styleCode="Botrule Rrule">13 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Abdominal pain^a</td><td align="center" valign="middle" styleCode="Botrule Rrule">7 </td><td align="center" valign="top" styleCode="Botrule Rrule">13 </td><td align="center" valign="top" styleCode="Botrule Rrule">14 </td><td align="center" valign="top" styleCode="Botrule Rrule">14 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Headache </td><td align="center" valign="middle" styleCode="Botrule Rrule">7 </td><td align="center" valign="top" styleCode="Botrule Rrule">8 </td><td align="center" valign="top" styleCode="Botrule Rrule">9 </td><td align="center" valign="top" styleCode="Botrule Rrule">9 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Abdominal distension </td><td align="center" valign="middle" styleCode="Botrule Rrule">3 </td><td align="center" valign="top" styleCode="Botrule Rrule">7 </td><td align="center" valign="top" styleCode="Botrule Rrule">9 </td><td align="center" valign="top" styleCode="Botrule Rrule">8 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Fatigue^a</td><td align="center" valign="top" styleCode="Botrule Rrule">4 </td><td align="center" valign="top" styleCode="Botrule Rrule">6 </td><td align="center" valign="top" styleCode="Botrule Rrule">7 </td><td align="center" valign="top" styleCode="Botrule Rrule">9 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Eructation </td><td align="center" valign="middle" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">6 </td><td align="center" valign="top" styleCode="Botrule Rrule">8 </td><td align="center" valign="top" styleCode="Botrule Rrule">8 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Gastroesophageal reflux disease </td><td align="center" valign="middle" styleCode="Botrule Rrule">2 </td><td align="center" valign="middle" styleCode="Botrule Rrule">6 </td><td align="center" valign="middle" styleCode="Botrule Rrule">6 </td><td align="center" valign="middle" styleCode="Botrule Rrule">7 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Flatulence </td><td align="center" valign="middle" styleCode="Botrule Rrule">2 </td><td align="center" valign="top" styleCode="Botrule Rrule">5 </td><td align="center" valign="top" styleCode="Botrule Rrule">6 </td><td align="center" valign="top" styleCode="Botrule Rrule">6 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Hair loss^a</td><td align="center" valign="top" styleCode="Botrule Rrule">2 </td><td align="center" valign="top" styleCode="Botrule Rrule">4 </td><td align="center" valign="top" styleCode="Botrule Rrule">4 </td><td align="center" valign="top" styleCode="Botrule Rrule">5 </td></tr></tbody></table>