Study Drug Administration. Please refer to Section 9.10.17 for details on study drug administration. Clear instructions will be provided to the patient regarding the number and type of capsules to be ingested at each study drug administration time point listed in Table 3. Patients must be instructed to continue taking study drug once daily up through their Week 24 visits unless: (1) patient has been otherwise instructed by the investigator or (2) the patient has been formally discontinued from the study.

Study Drug Administration. Patients under the age of 18 should self-administer one capsule from each bottle included in the study drug kit orally every other day for the first week after randomization, and begin dosing once a day on Day 7 through the end of the study, as indicated in Table 4. Adult patients (≥ 18 years of age) should self-administer one capsule from each bottle included in the study drug kit orally once a day beginning on Day 1 through the end of the study, as indicated in Table 4. Each dose of study drug should be administered at approximately the same time each day, preferably in the morning. On days when PK samples are collected, patients must not self- administer study drug. Study staff will administer study drug at the clinic following collection of the first PK sample.

Study Drug Administration. Prior to starting the injection procedure, RBM-007 should have been prepared as described in Section 7.4 and Section 7.5, and the study eye should have been prepared as described in Section 7.6. • The entry site for injection is 4.0 mm posterior to the corneal limbus. A caliper may be used to identify the needle entry site. • Insert the needle perpendicular to the eye wall at the location specified in Step 2 (Section 7.7) to inject the study solution into the vitreous cavity. Note: If paracentesis is considered necessary, it should be performed prior to injection of the RBM-007 and noted in the source documents. • Very slowly, inject the entire RBM-007 dose volume (50 µL or 100 µL) and slowly withdraw the needle. Do not pull back on the plunger at any time prior to withdrawing the needle.‌ • Briefly apply pressure for approximately 30 seconds to the needle entry site with sterile cotton tipped applicator (may be skipped per Clinical Investigator's discretion). • Remove the eyelid speculum and rinse the eye with sterile eye wash solution. • Patch the study eye at the Clinical Investigator's discretion. • Prescribe fluoroquinolone equivalent antibiotic eye drops three times/day for two days following injection, to be initiated as soon as possible.

Study Drug Administration. 5.1.3.1 NVP: one 200-mg tablet will be administered orally once daily for the first 14 days (lead-in period), then orally twice daily thereafter. In Step 1, NVP must be ingested in the morning during the lead-in period. The site clinician should review the signs and symptoms of NVP-related hypersensitivity and hepatitis with the participant prior to dispensing NVP. Participants should contact the site clinician as soon as possible if they develop rash, or signs and symptoms of hypersensitivity or hepatitis. If rash occurs during the lead-in period, do not escalate the dose until the rash has resolved. After reaching full dose, if NVP dosing is interrupted for >7 days, NVP should be started with the lead-in of 200 mg once daily for 14 days, then 200 mg twice daily. NVP may be taken with or without food. The lead-in period for NVP must never exceed 28 days. If the lead-in dosing period for NVP exceeds 28 daysd, then an alternate treatment must be sought. LPV/RTV: three soft-gel capsules (133.3 mg of LPV and 33.3 mg of RTV per capsule) will be administered orally twice daily with food. LPV/RTV: two fixed-dose combination tablets (each tablet contains 200 mg of lopinavir and 50 mg of ritonavir) orally twice daily with or without food. Tablets should be swallowed whole and not chewed, broken, or crushed. Lopinavir/ritonavir tablets will be available for all subjects who enroll under Version 3.0. Subjects who enrolled prior to Version 3.0 (i.e., before LPV/RTV tablets were available) may elect to switch from LPV/RTV capsules and receive the LPV/RTV tablets through A5208 at the time they consent to Version 3.0. A new prescription for the LPV/RTV tablets must be written in order for the pharmacist to dispense the new formulation.

Study Drug Administration. The intravitreal injection procedure using the pre-filled syringe should be carried out under controlled aseptic conditions. Adequate anaesthesia and a broad-spectrum microbicide should be given prior to the injection. Using aseptic technique, The study drug will be given by intravitreal injection 3.5 to 4mm posterior to the corneal scleral limbus. Following the intravitreal injection, subjects will be monitored for elevation in IOP and for endophthalmitis up to one-hour post-injection. Subjects should be instructed to report any symptoms suggestive of endophthalmitis without delay.

Study Drug Administration. Patients should self-administer one capsule from each bottle included in the study drug kit orally once a day, preferably in the morning, as indicated in Table 3. On days when PK samples are collected, patients must not self-administer study drug. Study staff will administer study drug at the clinic following collection of the first PK sample.‌‌‌‌ At the Week 24 visit, patients who opt to participate in a sub-study of 24-hr PK must not administer study drug before either day of the Week 24 visit. On the second day of the Week 24 visit, patients must administer study drug after the 24-hr PK blood collection has been performed. A vomited dose must not be replaced. A double dose (e.g., missed dose from previous day and dose for current day) must not be taken.

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FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.
Alcohol and Drug Testing Employee agrees to comply with and submit to any Company program or policy for testing for alcohol abuse or use of drugs and, in the absence of such a program or policy, to submit to such testing as may be required by Company and administered in accordance with applicable law and regulations.
Medicines To be filled in if your child requires medication as part of an individual health plan, for example for an on-going condition such as asthma or eczema etc and is for the use of that child only. For staff: Individual health plan sighted and a copy taken: Tick One: Yes No Name of medicine: Method and dose of medicine: When does the medicine need to be taken: (State time or specific symptoms) Parent/Guardian Signature: Date: / /  Enrolment Details: Date of Enrolment: / / Date of Entry: / / Date of Exit: / / Please Note: 20 Hours ECE is for up to six hours per day, up to 20 hours per week and there must be no compulsory fees when a child is receiving 20 Hours ECE funding. Days Enrolled: Monday Tuesday Wednesday Thursday Friday Times Enrolled: Total hours: 20 Hours ECE at this service Total hours: 20 Hours ECE at another service Total hours: Parent/Guardian Signature: Date: / /
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Prescription Drug Plan Retail and mail order prescription drug copays for bargaining unit employees shall be as follows:
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Alcohol and Drug-Free Workplace City reserves the right to deny access to, or require Contractor to remove from, City facilities personnel of any Contractor or subcontractor who City has reasonable grounds to believe has engaged in alcohol abuse or illegal drug activity which in any way impairs City's ability to maintain safe work facilities or to protect the health and well-being of City employees and the general public. City shall have the right of final approval for the entry or re-entry of any such person previously denied access to, or removed from, City facilities. Illegal drug activity means possessing, furnishing, selling, offering, purchasing, using or being under the influence of illegal drugs or other controlled substances for which the individual lacks a valid prescription. Alcohol abuse means possessing, furnishing, selling, offering, or using alcoholic beverages, or being under the influence of alcohol.
Alcohol and Drugs Service Provider agrees that the presence of alcohol and drugs are prohibited on the Work Site and while performing their Services. If the Service Provider or any of their agents, employees, or subcontractors are determined to be present or with alcohol or drugs in their possession, this Agreement shall terminate immediately.
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Function of Joint Health and Safety Committee All incidents involving aggression or violence shall be brought to the attention of the Joint Health and Safety Committee. The Employer agrees that the Joint Health and Safety Committee shall concern itself with all matters relating to violence to staff.

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