Occipital-frontal head circumference of participants in centimeter (cm) was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Occipital-frontal head circumference of participants in centimeter (cm) was reported.

Safety population included all participants who were enrolled into the study.

Occipital-frontal head circumference of participants in centimeter (cm) was reported.

Safety population included all participants who were enrolled into the study.

Occipital-frontal head circumference of participants in centimeter (cm) was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Occipital-frontal head circumference of participants in cm was reported.

Safety population analyzed. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for reporting arm "Maternal Exposure to Tramadol" had a visit within this window period, hence, for this reporting group no data was collected and reported.

Occipital-frontal head circumference of participants in cm was reported.

Safety population included all participants who were enrolled into the study.

Occipital-frontal head circumference of participants in cm was reported.

Safety population included all participants who were enrolled into the study.

Occipital-frontal head circumference of participants in cm was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period >21 to <=24 months for reporting arm "Maternal Exposure to Tramadol". Hence, for this reporting group no data was collected and reported.

Occipital-frontal head circumference of participants in cm was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period >24 to <=30 months for reporting arm "Maternal Exposure to Tramadol". Hence, for this reporting group no data was collected and reported.

Body length of participants in cm was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Body length of participants in cm was reported.

Safety population included all participants who were enrolled into the study.

Body length of participants in cm was reported.

Safety population included all participants who were enrolled into the study.

Body length of participants in cm was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Body length of participants in cm was reported.

Safety population analyzed. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for reporting arm "Maternal Exposure to Tramadol" had a visit within this window period, hence, for this reporting group no data was collected and reported.

Body length of participants in cm was reported.

Safety population included all participants who were enrolled into the study.

Body length of participants in cm was reported.

Safety population included all participants who were enrolled into the study.

Body length of participants in cm was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period >21 to <=24 months for reporting arm "Maternal Exposure to Tramadol". Hence, for this reporting group no data was collected and reported.

Body length of participants in cm was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period >24 to <=30 months for reporting arm "Maternal Exposure to Tramadol". Hence, for this reporting group no data was collected and reported.

Body weight of participants in kilogram (kg) was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Body weight of participants in kilogram (kg) was reported.

Safety population included all participants who were enrolled into the study.

Body weight of participants in kilogram (kg) was reported.

Safety population included all participants who were enrolled into the study.

Body weight of participants in kilogram (kg) was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Body weight of participants in kg was reported.

Safety population analyzed. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for reporting arm "Maternal Exposure to Tramadol" had a visit within this window period, hence, for this reporting group no data was collected and reported.

Body weight of participants in kg was reported.

Safety population included all participants who were enrolled into the study.

Body weight of participants in kg was reported.

Safety population included all participants who were enrolled into the study.

Body weight of participants in kg was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period >21 to <=24 months for reporting arm "Maternal Exposure to Tramadol". Hence, for this reporting group no data was collected and reported.

Body weight of participants in kg was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period >24 to <=30 months for reporting arm "Maternal Exposure to Tramadol". Hence, for this reporting group no data was collected and reported.

Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.

Safety population included all participants who were enrolled into the study.

Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Systolic and diastolic blood pressure of participants in mmHg was reported.

Safety population analyzed. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for "Maternal Exposure to Tramadol" had a visit within this window period; for "Maternal Exposure to Tanezumab" site missed to take participants' measurement. Thus, no data was collected and reported for both reporting arms.

Systolic and diastolic blood pressure of participants in mmHg was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Systolic and diastolic blood pressure of participants in mmHg was reported.

Safety population included all participants who were enrolled into the study.

Systolic and diastolic blood pressure of participants in mmHg was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period >21 to <=24 months for reporting arm "Maternal Exposure to Tramadol". Hence, for this reporting group no data was collected and reported.

Systolic and diastolic blood pressure of participants in mmHg was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period >24 to <=30 months for reporting arm "Maternal Exposure to Tramadol". Hence, for this reporting group no data was collected and reported.

Pulse rate of participants in beats per minute was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Pulse rate of participants in beats per minute was reported.

Safety population included all participants who were enrolled into the study.

Pulse rate of participants in beats per minute was reported.

Safety population included all participants who were enrolled into the study.

Pulse rate of participants in beats per minute was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Pulse rate of participants in beats per minute was reported.

Safety population analyzed. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for reporting arm "Maternal Exposure to Tramadol" had a visit within this window period, hence, for this reporting group no data was collected and reported.

Pulse rate of participants in beats per minute was reported.

Safety population included all participants who were enrolled into the study.

Pulse rate of participants in beats per minute was reported.

Safety population included all participants who were enrolled into the study.

Pulse rate of participants in beats per minute was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period >21 to <=24 months for reporting arm "Maternal Exposure to Tramadol". Hence, for this reporting group no data was collected and reported.

Pulse rate of participants in beats per minute was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period >24 to <=30 months for reporting arm "Maternal Exposure to Tramadol". Hence, for this reporting group no data was collected and reported.

Temperature of participants in degree Celsius was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Temperature of participants in degree Celsius was reported.

Safety population included all participants who were enrolled into the study.

Temperature of participants in degree Celsius was reported.

Safety population included all participants who were enrolled into the study.

Temperature of participants in degree Celsius was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Temperature of participants in degree Celsius was reported.

Safety population analyzed. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for reporting arm "Maternal Exposure to Tramadol" had a visit within this window period, hence, for this reporting group no data was collected and reported.

Temperature of participants in degree Celsius was reported.

Safety population included all participants who were enrolled into the study.

Temperature of participants in degree Celsius was reported.

Safety population included all participants who were enrolled into the study.

Temperature of participants in degree Celsius was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period >21 to <=24 months for reporting arm "Maternal Exposure to Tramadol". Hence, for this reporting group no data was collected and reported.

Temperature of participants in degree Celsius was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period >24 to <=30 months for reporting arm "Maternal Exposure to Tramadol". Hence, for this reporting group no data was collected and reported.

Respiratory rate of participants in breaths per minute was reported.

Safety population included all participants who were enrolled into the study. Here "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Respiratory rate of participants in breaths per minute was reported.

Safety population included all participants who were enrolled into the study.

Respiratory rate of participants in breaths per minute was reported.

Safety population included all participants who were enrolled into the study.

Respiratory rate of participants in breaths per minute was reported.

Safety population included all participants who were enrolled into the study. Here "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Respiratory rate of participants in breaths per minute was reported.

Safety population analyzed. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for reporting arm "Maternal Exposure to Tramadol" had a visit within this window period, hence, for this reporting group no data was collected and reported.

Respiratory rate of participants in breaths per minute was reported.

Safety population included all participants who were enrolled into the study.

Respiratory rate of participants in breaths per minute was reported.

Safety population included all participants who were enrolled into the study.

Respiratory rate of participants in breaths per minute was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period >21 to <=24 months for reporting arm "Maternal Exposure to Tramadol". Hence, for this reporting group no data was collected and reported.

Respiratory rate of participants in breaths per minute was reported.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period >24 to <=30 months for reporting arm "Maternal Exposure to Tramadol". Hence, for this reporting group no data was collected and reported.

Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.

Safety population included all participants who were enrolled into the study.

Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.

Safety population included all participants who were enrolled into the study.

Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.

Safety population analyzed. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm "Maternal Exposure to Tanezumab" to have follow up visit for neurological examination. No participant of reporting arm "Maternal Exposure to Tramadol" was suggested for follow up visit, thus no data reported for this arm.

Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.

Safety population analyzed. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm "Maternal Exposure to Tanezumab" to have follow up visit for neurological examination. No participant of reporting arm "Maternal Exposure to Tramadol" was suggested for follow up visit, thus no data reported for this arm.

BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.

Safety population included all participants who were enrolled into the study.

BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.

Safety population included all participants who were enrolled into the study.

BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.

Safety population analyzed. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm "Maternal Exposure to Tanezumab" to have follow up visit for BINS assessment. No participant of reporting arm "Maternal Exposure to Tramadol" was suggested for follow up visit, thus no data reported for this arm.

BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance. Data collected at age of 26 months used 24 months' age items.

Safety population analyzed. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm "Maternal Exposure to Tanezumab" to have follow up visit for BINS assessment. No participant of reporting arm "Maternal Exposure to Tramadol" was suggested for follow up visit, thus no data reported for this arm.

REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.

Safety population included all participants who were enrolled into the study.

REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.

Safety population included all participants who were enrolled into the study.

REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.

Safety population analyzed. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm "Maternal Exposure to Tanezumab" to have follow up visit for REEL-3 assessment. No participant of reporting arm "Maternal Exposure to Tramadol" was suggested for follow up visit, thus no data reported for this arm

REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.

Safety population analyzed. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm "Maternal Exposure to Tanezumab" to have follow up visit for REEL-3 assessment. No participant of reporting arm "Maternal Exposure to Tramadol" was suggested for follow up visit, thus no data reported for this arm