Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households

Influenza Clinical Trial

Official title:

A Phase IIIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Clinical Efficacy Study of Baloxavir Marboxil for the Reduction of Direct Transmission of Influenza From Otherwise Healthy Patients to Household Contacts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03969212
• Other study ID #: MV40618
• Secondary ID: 2018-004056-37
• Status: Completed
• Phase: Phase 3
• Start date: October 10, 2019
• Est. completion date: May 10, 2024

Study information

• Verified date: May 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 1 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the assessment of symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4176
• Est. completion date: May 10, 2024
• Est. primary completion date: May 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 64 Years

Eligibility

INCLUSION CRITERIA:

Index Patients (IPs):

• Able to comply with the study protocol per investigator judgment.

• Diagnosed with acute influenza infection by investigator.

• Polymerase chain reaction [PCR] (+) or Rapid Influenza Diagnostic Test [RIDT] (+) for influenza A/B based on cobas® SARS-CoV-2 and influenza A/B or other point-of-care / local laboratory results.

• PCR (-) or antigen test (-) for SARS-CoV-2 based on cobas® SARS-CoV-2 and Influenza A/B test or other point-of-care / local laboratory result

• Presence of (a) fever (>=38.0 °C per tympanic or rectal thermometer; >=37.5 °C per axillary, oral or forehead/temporal thermometer) or (b) any influenza symptoms (cough, sore throat, nasal congestion, headache, feverishness or chills, muscle or joint pain, fatigue).

• The time interval between the onset of fever or influenza symptoms and the pre-dose examinations is 48 hours or less.

• IP lives in a household where: (1) No HHC is known to have been diagnosed with influenza or SARS-CoV-2 infection by a healthcare professional (HCP) in the past 4 weeks; (2) All HHCs are expected to meet the key HHC inclusion criteria; (3) >=1 HHCs are expected to participate in the full study who have not received the influenza vaccine within 6 months prior to screening.

• Women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures specified in the protocol

All HHCs (Part 1):

• PCR (-) or RIDT (-) based on cobas® SARS-CoV-2 and influenza A/B or other local point-of-care / local laboratory result.

• PCR (-) or antigen test (-) for SARS-CoV-2 based on cobas® SARS-CoV-2 and Influenza A/B or other POC / local laboratory result.

• HHC lives with no HHC who will be present in the home at any time during the study and who meets any HHC exclusion criteria.

• HHC lives with no HHC who does not meet HHC inclusion criteria (part 1).

• HHC lives in a household where =1 HHCs meet all of the following: Start screening within 24 hours after IP randomization; Have NOT received the influenza vaccine within 6 months prior to screening; and Fulfill full study HHC inclusion criteria part 2.

Full study HHCs (part 2) intended for full study must meet the following additional criteria for study entry:

• Agree to participate in the full study.

• Able to comply with the study protocol per investigator judgment

• No influenza symptoms within 7 days prior to screening. Alternatively, mild symptoms are permissible if determined by the investigator to be due to a preexisting condition.

• Temperature <38.0 °C (tympanic).

• Will reside in the index patient's house for at least 7 of the next 9 days and will be present for scheduled study visits.

• Willing and able to measure and record temperature, or have another household member perform the task on his or her behalf. Furthermore, a responsible adult will assume responsibility to oversee or perform this task on behalf of minors.

• In the 6 months prior to screening: a) Has not been diagnosed with influenza by a healthcare professional b) Has not received BXM, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, favipiravir or amantadine.

• Does not have a moderate or worse active infections OR infections requiring systemic (e.g., oral or intravenous) or otherwise internally administered (e.g., inhaled, intrathecal) antibiotic/antiviral/antifungal therapy, (topical therapies for mild external infections allowed).

EXCLUSION CRITERIA:

IPs:

• IPs with severe influenza virus infection requiring inpatient treatment.

• IPs judged by the investigator to be at high risk for complications of influenza.

• IP is =12 years old and unable to swallow tablets (not applicable to IPs 5 to 11 year olds who will receive oral suspension).

• Women who are breastfeeding or have a positive pregnancy test in the pre-dose examinations.

• IPs with concurrent (non-influenza) infections requiring systemic antimicrobial and/or antiviral therapy at the pre-dose examinations.

• IPs who have received baloxavir marboxil, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, favipiravir or amantadine, or an investigational drug, within 30 days or 5 drug-elimination half-lives, whichever is longer, prior to screening.

• IPs who have received an investigational monoclonal antibody for a viral disease in the last year.

• Known hypersensitivity to baloxavir marboxil or the drug product excipients.

• IP previously included in the study

• IP lives with an HHC who, based on available information, meets the HHC exclusion criteria

HHC:

• Pregnant or within 2 weeks post-partum at screening.

• Immunocompromised.

• Less than 2 years old.

• Who have received an investigational therapy within the 30 days or 5 drug elimination half-lives, whichever is longer, prior to screening.

• Diagnosed with influenza or SARS-CoV-2 infection by a healthcare professional in the past 4 weeks.

• HHC who plans to arrive home after 24 hours post IP randomization to Day 9 and is not willing to be consented as soon as possible upon arrival.

• HHC previously included in the study.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• Baloxavir Marboxil
IPs less than 12 years old will receive either 2 mg/kg (if weight less than 20 kg) or 40 mg (if weight more than or equal to 20 kg) of Baloxavir Marboxil as oral suspension. IPs more than or equal to 12 years old will receive either 40 mg (if weight less than 80 kg) or 80 mg (if weight more than or equal to 80 kg) of Baloxavir Marboxil as tablets. HHCs of IPs will not receive study medication.
• Placebo
IPs less than 12 years old will receive placebo oral suspension and those above 12 years will receive placebo tablets. HHCs of IPs will not receive study medication.

Locations

Country	Name	City	State
Bulgaria	Medical Centre "Asklepii", OOD; Office of Pulmonology and Phtisiatrics	Dupnitsa
Bulgaria	Medical Center Zdrave 1; Office of Pulmonology and Phtisiatrics	Kozloduy
Bulgaria	MEDICAL CENTER HERA EOOD; Office of Pulmonology and Phtisiatrics	Montana
Bulgaria	MHAT Stamen Iliev AD; Deparment of Infectious Diseases	Montana
Bulgaria	MHAT Sveta Paraskeva; Office of Cardiology Diseases	Pleven
Bulgaria	SHAT for Pneumo-Phtysiatric Diseases ?Dr. Dimitar Gramatikov? EOOD; Department of Pneumology	Ruse
Bulgaria	SHAT for Pneumo-Phtysiatric Diseases ?Dr. Dimitar Gramatikov?; Dept. of Pulmonology and Phtisiatrics	Ruse
Bulgaria	Medizinski Zentrar-1-Sevlievo EOOD; Office of Pulmonology and Phtisiatrics	Sevlievo
Bulgaria	MHAT Sliven - Military Medial Academy; Department of Infectious Diseases	Sliven
Bulgaria	Medical Center Hera Sofia; Office of Pulmonology and Phtisiatrics	Sofia
Bulgaria	MHAT Sveta Sofia; Oncology Department	Sofia
China	Beijing Ditan Hospital	Beijing
China	Beijing Children's Hospital, Capital Medical University	Beijing City
China	Beijing Tsinghua Changgung Hospital	Beijing City
China	Beijing You An Hospital; Digestive Dept	Beijing City
China	Capital Medical University Beijing Hospital of Traditional Chinese Medicine	Beijing City
China	China-Japan Friendship Hospital	Beijing City
China	West China Hospital, Sichuan University	Chengdu
China	Guangzhou Women and Children's Medical Center	Guangzhou
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	Liaocheng people's Hospital	Liaocheng City
China	Children's hospital of Nanjing medical university	Nanjing City
China	The Third People's Hospital of Hainan Province	Sanya
China	Zhongshan Hospital Fudan University	Shanghai
China	Shenzhen People's Hospital	Shenzhen
China	Shenzhen children's hospital	Shenzhen City
China	Taizhou People's Hospital; Infectious Diseases	Taizhou City
China	The First Affiliated Hospital of Wenzhou Medical College	Wenzhou
China	Tongji Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan City
China	General Hospital of Ningxia Medical University	Yinchuan
China	Henan Provincial People's Hospital	Zhengzhou
China	Zibo Municipal Hospital.	ZIbo
Costa Rica	ICIMED Instituto de Investigación en Ciencias Médicas	San José
Greece	Laiko General Hospital - Uni of Athens; 1St Dept. of Internal Medicine	Athens
Greece	Sotiria General Hospital of Athens; 3rd Department of Internal Medicine	Athens
Greece	Attikon University General Hospital; 4th Academic Department of Internal Medicine	Chaidari
Hungary	Obudai Egeszsegugyi Centrum Kft.	Budapest
Hungary	II. Háziorvosi Körzet	Hosszúhetény
Hungary	Gyermekháziorvosi rendel?- Dr. Újhelyi János	Nyíregyháza
Hungary	OEC Clinical Research	Zalaegerszeg
India	Sterling Hospital; Clinical Research Department	Ahmedabad	Gujarat
India	JLN Medical College and Hospital; TB and Chest Department	Ajmer	Rajasthan
India	Apollo Hospitals	Bangalore South	Karnataka
India	Mazumdar Shaw Medical Centre- A unit of Narayana Hrudayalaya	Bangalore South	Karnataka
India	AIG Hospitals	Gachibowli	Telangana
India	Kanoria Hospital & Research Centre	Gandhi Nagar	Gujarat
India	Medanta-The Medicity	Gurgaon	Haryana
India	Medical College and Hospital- Kolkata	Kolkata	WEST Bengal
India	Ajanta Research centre; Research Department	Lucknow	Uttar Pradesh
India	M.V Hospital and Research Centre; Research Hall	Lucknow	Uttar Pradesh
India	Sir J J Group of Hospitals; Department of Pulmonary Medicine	Mumbai	Maharashtra
India	JSS Hospital; Department of clinical pharmacy	Mysuru	Karnataka
India	Criticare Hospital & Research Institute; Research department	Nagpur	Maharashtra
India	Sir Gangaram Hospital	NEW Delhi Delhi	Delhi
India	Lifepoint Multispeciality Hospital; Clinical research department.	Pune	Maharashtra
India	Jehangir Clinical development Centre Pvt Ltd.	Pune City	Maharashtra
India	MTES's Sanjeevan Hospital	Pune City	Maharashtra
India	Kasturba Medical College and Hospital; Department of Medicine	Udupi	Karnataka
Israel	Siaal Research Center for Family Medicine and Primary Care; Clalit Neve Zeev	Beer-Sheva
Israel	Kiryat Motzkin Maccabi Medical Center	Kiryat Motzkin
Israel	Clalit Health Services- Pediatric Ambulatory Clinic; Pediatric Ambulatory Clinic	Petach Tikva
Israel	Maccabi health services - Moked Hashalom	Tel Aviv
Japan	Toda Internal Medicine & Neurology Clinic	Akashi
Japan	Medical Corporation Houmankai?Umezu?Clinic	Chikushino
Japan	Kashinoki Internal Medicine Clinic	Date
Japan	Fukuoka Shin Mizumaki Hospital	Fukuoka
Japan	Fukuoka Wajiro Hospital	Fukuoka
Japan	Irie Naika Syounika Iin	Fukuoka
Japan	Kimura Siro Clinic	Fukuoka
Japan	Shin Komonji Hospital	Fukuoka
Japan	Iguchi Clinic	Fukuyama
Japan	Kyoaikai Hospital	Hakodate
Japan	Mashiba Clinic	Hanno
Japan	Fujimaki Ent Clinic	Ichikawa
Japan	Hisaki Family Clinic	Ichikawa
Japan	Kamoike ENT Allergy Clinic	Kagoshima
Japan	Moriyama Otolaryngology	Kagoshima
Japan	Clinic Kashiwanoha	Kashiwa
Japan	Kamezawa Clinic	Kasugai
Japan	Oishi Clinic	Kasuyagun
Japan	Kanagawa Himawari Clinic	Kawasaki
Japan	Takahashi naika	Kawasaki
Japan	Takinogawa Gastroenterology Hosipital	Kita
Japan	Morizono medical clinic	Kitakyushu
Japan	Osaki Internal and Respiratory Clinic,	Kitakyushu
Japan	Sato ENT Clinic	Kitakyushu
Japan	JA Kochi Hospital	Kochi
Japan	Kiheibashi Otolaryngology	Kodaira
Japan	Medical corporation Shirayurikai Swing Nozaki Clinic	Musashino
Japan	Onaka Naika Higashishirakabe Clinic	Nagoya,
Japan	Yaesu Clinic	Naha
Japan	Horikawa Clinic	Nonoichi
Japan	Funai Ear Nose Throat Clinic	Oita
Japan	Kikumori Ear, Nose and Throat Clinic	Osaka
Japan	Kitada Clinic	Osaka
Japan	Lee's Clinic	Osaka
Japan	Manabe?Clinic	Osaka
Japan	Sunami Internal medicine Clinic	Osaka
Japan	Saga Memorial Hospital	Saga
Japan	Medical Corporation Saitadayoshikai Saikatsu Clinic	Saitama
Japan	Segawa Hospital	Saitama
Japan	Aiiku Hospital	Sapporo
Japan	Uehara Clinic	Sapporo
Japan	Matsuo Kenko Clinic	Sendai
Japan	Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai	Shinagawa
Japan	Wakasa Clinic	Tokorozawa
Japan	Denenchofu Family Clinic	Tokyo
Japan	Miyazaki RC Clinic	Tokyo
Japan	Sato Clinic	Tokyo
Japan	Seiwa Clinic	Tokyo
Japan	Sekino Hospital	Toshima
Japan	Takeru CLINIC	Toyohashi
Japan	Tsuchiura Beryl Clinic	Tsuchiura
Japan	Medical corporation Seijinkai Takei Clinic	Tsuru
Japan	Gushiken-Cardiology and Internal medicine	Urasoe
Japan	Uranishi Clinic	Urasoe
Japan	Yotsukaido Tokushukai Medical Center	Yotsukaido
Mexico	Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.	Guadalajara	Jalisco
Mexico	EME RED	Mérida	Yucatan
Mexico	Merida | Investigacion Clinica	Mérida	Yucatan
Mexico	Centro Respiratorio de México	Mexico	Mexico CITY (federal District)
Mexico	CEPREP; Hospital Universitario	Monterrey	Nuevo LEON
Mexico	Centro de Estudios Clinicos de Queretaro (CECLIQ)	Querétaro	Queretaro
New Zealand	Lakeland Clinical Trials Waikato	Hamilton
New Zealand	Lakeland Clinical Trials Rotorua	Rotorua
New Zealand	Lakeland Clinical Trials Wellington	Wellington
Poland	KLIMED	Bia?ystok
Poland	NZOZ Vitamed	Bydgoszcz
Poland	Centrum Medyczne Lukamed Joanna Luka	Chojnice
Poland	Anchor Meds - Kalisz	Kalisz
Poland	Centrum Medyczne Pulawska SP. z o.o.	Piaseczno
Poland	IRMED Osrodek Badan Klinicznych	Piotrków Trybunalski
Poland	KO-MED Centra Kliniczne Sp. z o.o.; Osrodek Badan Klinicznych	Pu?awy
Poland	CLINHOUSE Sp z o.o.	Zabrze
Puerto Rico	Fundacion de Investigacion de Diego	San Juan
Singapore	National Healthcare Group Polyclinics- Yishun	Singapore
South Africa	Somerset West Clinical Trial Unit	Cape Town
South Africa	Into Research; Life Groenkloof Hospital Medical Centre	Groenkloof
South Africa	Newtown Clinical Research	Johannesburg
South Africa	Langeberg Clinical Trials	Kraaifontein
South Africa	Midrand Medical Centre	Midrand
Spain	Centro de Salud Las Aguilas; Medicina General	Madrid
Turkey	Ankara Bilkent City Hospital	Ankara
Turkey	Ankara University Faculty of Medicine Cebeci Hospital	Ankara
Turkey	Gazi University Medical Faculty	Ankara
Turkey	Hacettepe University Medical Faculty; Infectious Diseases	Ankara
Turkey	Akdeniz University Medical Faculty	Antalya
Turkey	Atakent Acibadem Private Hosptial Halkali Merkez Mh.,	Istanbul
Turkey	Koc University Medical Faculty; Department of Gynecology & Obstetrics	Istanbul
Turkey	Dokuz Eylul University Medical Faculty; Infection	Izmir
Turkey	Ege University Medical Faculty	Izmir
Turkey	Kocaeli University Medical Faculty	Kocaeli
Turkey	Karadeniz Technical Uni School of Medicine; Infection Diseases & Clinical Mikrobiology Dept	Trabzon
United Kingdom	Preston Hill Surgery	Harrow
United States	Cahaba Research, Inc.	Birmingham	Alabama
United States	Central Alabama Research; Pediatrics	Birmingham	Alabama
United States	Mercury Street Medical Group	Butte	Montana
United States	Hope Clinical Research	Canoga Park	California
United States	OnSite Clinical Solutions LLC	Charlotte	North Carolina
United States	AFC Urgent Care-Gunbarrell	Chattanooga	Tennessee
United States	Hometown Urgent Care and Occupational Health - Springdale	Cincinnati	Ohio
United States	City Doc Urgent Care-Dallas/Ft. Worth	Dallas	Texas
United States	Southwest Family Medicine Associates	Dallas	Texas
United States	Fairway Medical Clinic	Houston	Texas
United States	Mercury Clinical Research	Houston	Texas
United States	Pioneer Research Solutions	Houston	Texas
United States	Vilo Research Group	Houston	Texas
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	Helios Clinical Research, Inc (former Ventavia Research Group)	Kissimmee	Florida
United States	Accent Clinical Trials	Las Vegas	Nevada
United States	Excel Clinical Research	Las Vegas	Nevada
United States	Long Beach Clinical Trials	Long Beach	California
United States	Downtown LA Research Center	Los Angeles	California
United States	Cordova Research Institute, LLC	Miami	Florida
United States	Research Institute of South Florida Inc	Miami	Florida
United States	South Florida Research Center, Inc.	Miami	Florida
United States	Mishawaka Osteopathic Clinic	Mishawaka	Indiana
United States	Montana Medical Research LLC	Missoula	Montana
United States	Burke Primary Care	Morganton	North Carolina
United States	Nemours Children's Hospital; Nemour's Research Institute	Orlando	Florida
United States	Cahaba Research, Inc	Pelham	Alabama
United States	Tristar Clinical Investigations	Philadelphia	Pennsylvania
United States	Precision Trials	Phoenix	Arizona
United States	Probe Clinical Research	Riverside	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Sun Research Institute	San Antonio	Texas
United States	MD Strategies Research Centers	San Diego	California
United States	Frontier Clinical Research	Smithfield	Pennsylvania
United States	Kendall South Medical Center Inc.	South Miami	Florida
United States	Oakland Medical Research	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Bulgaria,  China,  Costa Rica,  Greece,  Hungary,  India,  Israel,  Japan,  Mexico,  New Zealand,  Poland,  Puerto Rico,  Singapore,  South Africa,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virological Transmission by Day 5	Defined as the percentage of Household Contacts (HHCs) who become Polymerase Chain Reaction Positive (PCR+) for Influenza by Day 5 post IP randomization. HHCs may be symptomatic or asymptomatic and their virus subtype must match that of the index patient (IP) in their household. The primary efficacy analysis population will consist of all enrolled unvaccinated HHCs of the randomized IPs.	Baseline to Day 5 (5 days)
Secondary	Symptomatic Transmission by Day 5	Defined as the percentage of HHCs who become PCR+ for Influenza by Day 5 post IP randomization and develop Influenza symptoms at any time during the study. HHCs =12 years old were defined symptomatic if (1) Presence of temperature =38.0 Celsius and one respiratory symptom (cough, sore throat, nasal congestion) or (2) Presence of one respiratory symptom and one general systemic symptom (headache, feverishness or chills, muscle or joint pain, fatigue), with or without fever. HHCs =2 and <12 years old were defined symptomatic if presence of temperature =38.0 Celsius and cough, nasal congestion, or rhinorrhea. Note: For HHCs of any age, respiratory or general systemic symptoms had to be either (1) new, or (2) worsened versus baseline with baseline symptoms due to a pre-existing comorbidity. HHCs must have their virus subtype match that of the IP.	Baseline to Day 5 (5 days)
Secondary	Virological Transmission at the Household Level by Day 5	Defined as the percentage of households with at least one HHC who meets the primary endpoint.	Baseline to Day 5 (5 days)
Secondary	Symptomatic Transmission at the Household Level by Day 5	Defined as the percentage of households with at least one HHC who meets the "Symptomatic transmission by Day 5 endpoint.	Baseline to Day 5 (5 days)
Secondary	Virological Transmission by Day 9	Defined as the percentage of HHCs who become PCR+ for Influenza by Day 9 post IP randomization. HHCs must have their virus subtype match that of the IP, and include: (1) all HHC meeting primary endpoint, AND (2) all HHC cases detected after Day 5 Visit meeting the following criteria: (2a) included HHC case is in a household where another HHC has already met the primary endpoint, OR (2b) included HHC case is PCR (+) for influenza bearing an amino acid substitution of isoleucine for another amino acid at position 38 (I38X) in the polymerase acidic (PA) protein, that have been associated with reduced susceptibility to baloxavir marboxil.	Baseline to Day 9 (9 days)
Secondary	Symptomatic Transmission by Day 9	Defined as the percentage of HHCs who meet the "Virological transmission by Day 9" endpoint AND are symptomatic per the definition for symptoms in the "Symptomatic transmission by Day 5" endpoint.	Baseline to Day 9 (9 Days)
Secondary	Any Virological Infection by Day 9	Defined as the percentage of HHCs who become PCR (+) for influenza (confirmed at central laboratory) by Day 9.	Baseline to Day 9 (9 Days)
Secondary	Any Virological Infection at the Household Level by Day 9	Defined as the percentage of households with at least one HHC who meets the "Any virological infection by Day 9" endpoint.	Baseline to Day 9 (9 Days)
Secondary	Any Symptomatic Infection by Day 9	Defined as the percentage of HHCs who meet the "Any virological infection by Day 9" endpoint AND are symptomatic per the definition for symptoms in the "Symptomatic transmission by Day 5" endpoint.	Baseline to Day 9 (9 Days)
Secondary	Any Symptomatic Infection at the Household Level by Day 9	Defined as the percentage of households with at least one HHC who meets the "Any symptomatic infection by Day 9" endpoint.	Baseline to Day 9 (9 Days)
Secondary	Percentage of IPs With Adverse Events (AEs)		Baseline to Day 9 (for IPs =12 years old) and Day 21 (for IPs <12 years old)
Secondary	Percentage of IPs (<= 12 years old) Reporting each Palatability and Acceptability Response	The Palatability and Acceptability questionnaire consists of 2 questions: 1) How was the taste of this medicine; 2) Would you be happy to take this medicine again. Response for question (1) will be captured on a Likert scale (1-5) and for question (2) will be either Yes, No, or Not Sure/No Answer.	Baseline